Product delivery mechanism issue, No adverse event
Drugs: ALBUTEROL SULFATE
- Safetyreportversion
- 1
- Safetyreportid
- 27325184
- Primarysourcecountry
- US
- Occurcountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20261008
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 1
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Companynumb
- US-AMNEAL PHARMACEUTICALS-2026-AMRX-04265
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- AMNEAL
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Product delivery mechanism issue
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- No adverse event
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- ALBUTEROL SULFATE
- Drugbatchnumb
- AI26002
- Drugauthorizationnumb
- 211600
- Drugseparatedosagenumb
- 4
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 90 MCG, 2 PUFFS EVERY 04 TIMES A DAY
- Drugdosageform
- AEROSOL, METERED
- Drugindication
- Asthma
- Drugstartdateformat
- 102
- Drugstartdate
- 20260910
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- ALBUTEROL SULFATE
- Harmonized identifiers (openFDA)
- Application number
- ANDA077788, ANDA209959, ANDA072151, NDA020983, ANDA219409, ANDA077839, ANDA211888, ANDA203760, ANDA209954, ANDA211600, ANDA076355, ANDA212447, ANDA075664, ANDA074880, ANDA215571, ANDA072637, ANDA207085, ANDA207857, ANDA218386, ANDA212197, NDA020503, ANDA214531
- Brand name
- ALBUTEROL SULFATE, VENTOLIN HFA, ALBUTEROL, ALBUTEROL SULFATE INHALATION, ALBUTEROL SULFATE HFA, ALBUTEROL SULFATE INHALATION SOLUTION, 0.5%, ALBUTEROL SULFATE INHALATION SOLUTION
- Generic name
- ALBUTEROL SULFATE
- Manufacturer name
- Chartwell RX, LLC, American Health Packaging, GlaxoSmithKline LLC, Cipla USA Inc., Mylan Pharmaceuticals Inc., Luoxin Aurovitas Pharma (Chengdu) Co., Ltd., Padagis Israel Pharmaceuticals Ltd, Lupin Pharmaceuticals, Inc., Amneal Pharmaceuticals NY LLC, Prasco Laboratories, Nephron Pharmaceuticals Corporation, Ritedose Pharmaceuticals, LLC, Armstrong Pharmaceuticals, Inc., Chartwell RX, LLC., Exelan Pharmaceuticals, Inc., Rising Pharma Holdings, Inc., Rising Pharma Holdings, Inc, Ingenus Pharmaceuticals, LLC, Sun Pharmaceutical Industries, Inc., Chartwell Governmental & Specialty RX, LLC., Hikma Pharmaceuticals USA Inc., Aurobindo Pharma Limited, QUAGEN PHARMACEUTICALS LLC, Sandoz Inc
- Product NDC
- 62135-189, 60687-662, 62135-671, 62135-672, 0173-0682, 69097-021, 0378-8270, 81894-105, 81894-106, 45802-088, 68180-963, 69238-1291, 60687-395, 66993-019, 0487-0301, 0487-9904, 76204-200, 17270-0740, 62135-829, 76282-679, 64980-641, 64980-643, 64980-644, 50742-392, 50742-393, 64980-642, 62135-826, 62135-827, 53489-176, 53489-177, 69097-142, 68999-189, 0054-0742, 59651-183, 59651-184, 47335-703, 76204-027, 62135-828, 70752-102, 0781-7296 +2 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL, RESPIRATORY (INHALATION)
- Substance name
- ALBUTEROL SULFATE
- RxCUI
- 755497, 2123111, 197316, 197318, 801092, 801095, 859088, 2123076, 630208, 351136, 351137, 2123072, 245314
- SPL ID
- 316befe4-1351-2acb-e063-6394a90a9a17, 5242a3fe-0a61-251c-e063-6294a90ad050, fe7cbf82-9f32-327e-e053-6294a90aebc8, 08d3613c-b059-4e06-b42c-591a129f1649, 7d4c1e96-c05f-4ffc-80b6-988986a061bc, 94ad4684-ceb9-4c5e-9635-a6edb5904ccc, 1d6bfa3d-ae1f-8167-e063-6394a90a2356, 0ce1f4c5-3283-4e4d-a107-d82c8e78ee84, ca017981-2752-46e0-9a66-418535597d31, 881ca107-7a62-40e0-8936-89bc2d16cfa6, 54eddfbb-f919-1e84-e063-6294a90add14, 70817038-c7c0-4978-b5a2-0f6a0267ae33, 4ecf4a2e-bc85-7019-e063-6394a90a3202, 4ffe0388-e743-7259-e063-6394a90a94d2, aabe1b11-7f84-4db3-9d05-0c79a4a88ba2, 11e58070-ecf6-06b9-e063-6394a90adaba, 3449ab68-28d3-42f5-8d34-329bf6fa0e6b, 56c01144-7ba7-2f75-e063-6294a90a6e6f, 56c0a24f-4608-be23-e063-6294a90a9be2, 250b033d-3ed5-c0d1-e063-6394a90a93c9, 56c00cc1-5ed0-8ff5-e063-6394a90a132b, 11e59625-431b-e530-e063-6294a90a0596, 4d289f6d-634d-2125-e063-6394a90aa25d, 135ef57d-f447-45c6-ad56-e4f772dc98ee, 462ca25f-d461-c069-e063-6394a90a528a, 07a1b9ad-58cb-4c21-b8df-6854da990f85, 1e853c87-b534-65d2-e063-6394a90a7923, e48295e4-b6c1-434a-aa5f-25d900f1f16a, 4e7f86ab-55bc-c123-e063-6394a90abd8d, 11e5a7ae-f1eb-ea1f-e063-6294a90a0efb, f8b35fdc-741f-4ebd-91d5-a55a7ef8e261, 44ec30c6-e178-d2ed-e063-6394a90a25a5, 4ffd498d-4575-dd61-e063-6394a90a95d6
- SPL set ID
- 560df50c-e2c4-459f-9d89-bf7e6588949e, b0a5da99-6553-4088-ae27-7fa194438340, 81cdae6f-99d7-468b-9ab8-fecb1d42298d, d92c5d6b-ff10-4087-36a2-1cfc464cb967, fd0389e0-3713-42e0-8ef2-3bb97676fded, 5329614f-ae0b-4854-bb6f-ea0b7dae87c0, 1d6be2b8-c670-b783-e063-6294a90ae503, 489201d2-9ed0-419b-81dc-a7f7f86b59ed, 973b8686-c6ce-4280-85c4-c1e7ceab3c09, 2e449282-ee58-4e36-b983-85c4e6f0864d, 4aec7f59-b429-4b0e-a779-8df1dd8f80d7, b25d9d6b-eb4c-452e-89ef-10e611deebd6, 285a656c-f77f-4e77-b0a8-a0e9c901803f, b72742df-1a6b-4483-aff3-3e79db5e015d, 17858afa-dcdf-4612-b475-3b6baadfb639, 7f261a9b-65d9-408a-8609-c1b3809b8b4b, 29e35e54-dbd6-4426-993f-893d7a4d69be, 32377c09-da6d-331c-e063-6294a90a7a46, 32474c0e-af35-69d1-e063-6394a90a53c6, e14f5fd6-d01a-489d-9baa-61778b1352a8, 3236f82c-14e9-dfd4-e063-6294a90ac43d, 4e48ccbe-3ec0-4bf2-be28-83eb9baa63d6, 87b8cd3c-2849-4b50-b63e-9ea379165c07, c4d6d76a-14b8-411a-8019-e2c923c2c532, dd47559a-84f6-42a5-a00e-48754505418e, 6c64ab5d-f8a2-440a-a929-cb8188d0e8b4, 78e6bee2-7113-46cf-8c97-dc61b0f7b94f, bb538b7d-e390-419a-9404-a57c1db4a447, fdb4ac5a-bf0d-4896-89f7-1828c081b79e, 922bf33b-4d55-4c35-9f68-72efbb17c14f, 99a490cc-e41d-436b-9cf3-8facb7ac714f, f8a2c4b7-a162-48ab-90b0-350e4da25c66, d4c532be-1f41-60d3-e053-2995a90a98be
- Package NDC
- 62135-189-41, 62135-189-47, 62135-189-05, 62135-189-24, 62135-189-20, 62135-189-23, 60687-662-91, 62135-671-90, 62135-672-90, 0173-0682-20, 0173-0682-24, 69097-021-60, 0378-8270-62, 0378-8270-52, 0378-8270-93, 0378-8270-64, 0378-8270-91, 0378-8270-31, 0378-8270-55, 81894-105-25, 81894-105-30, 81894-106-25, 81894-106-30, 45802-088-01, 68180-963-01, 69238-1291-1, 60687-395-79, 60687-395-83, 66993-019-68, 0487-9904-25, 0487-9904-01, 0487-9904-02, 0487-0301-01, 0487-0301-02, 76204-200-25, 76204-200-30, 76204-200-60, 76204-200-01, 17270-0740-0, 62135-829-84 +49 more
- UNII
- 021SEF3731
- Drugcharacterization
- 1
- Medicinalproduct
- ALBUTEROL SULFATE
- Drugauthorizationnumb
- 211600
- Drugdosagetext
- UNK
- Drugdosageform
- AEROSOL, METERED
- Actiondrug
- 6
- Drugadditional
- 4
- Activesubstance
- Activesubstancename
- ALBUTEROL SULFATE
- Harmonized identifiers (openFDA)
- Application number
- ANDA077788, ANDA209959, ANDA072151, NDA020983, ANDA219409, ANDA077839, ANDA211888, ANDA203760, ANDA209954, ANDA211600, ANDA076355, ANDA212447, ANDA075664, ANDA074880, ANDA215571, ANDA072637, ANDA207085, ANDA207857, ANDA218386, ANDA212197, NDA020503, ANDA214531
- Brand name
- ALBUTEROL SULFATE, VENTOLIN HFA, ALBUTEROL, ALBUTEROL SULFATE INHALATION, ALBUTEROL SULFATE HFA, ALBUTEROL SULFATE INHALATION SOLUTION, 0.5%, ALBUTEROL SULFATE INHALATION SOLUTION
- Generic name
- ALBUTEROL SULFATE
- Manufacturer name
- Chartwell RX, LLC, American Health Packaging, GlaxoSmithKline LLC, Cipla USA Inc., Mylan Pharmaceuticals Inc., Luoxin Aurovitas Pharma (Chengdu) Co., Ltd., Padagis Israel Pharmaceuticals Ltd, Lupin Pharmaceuticals, Inc., Amneal Pharmaceuticals NY LLC, Prasco Laboratories, Nephron Pharmaceuticals Corporation, Ritedose Pharmaceuticals, LLC, Armstrong Pharmaceuticals, Inc., Chartwell RX, LLC., Exelan Pharmaceuticals, Inc., Rising Pharma Holdings, Inc., Rising Pharma Holdings, Inc, Ingenus Pharmaceuticals, LLC, Sun Pharmaceutical Industries, Inc., Chartwell Governmental & Specialty RX, LLC., Hikma Pharmaceuticals USA Inc., Aurobindo Pharma Limited, QUAGEN PHARMACEUTICALS LLC, Sandoz Inc
- Product NDC
- 62135-189, 60687-662, 62135-671, 62135-672, 0173-0682, 69097-021, 0378-8270, 81894-105, 81894-106, 45802-088, 68180-963, 69238-1291, 60687-395, 66993-019, 0487-0301, 0487-9904, 76204-200, 17270-0740, 62135-829, 76282-679, 64980-641, 64980-643, 64980-644, 50742-392, 50742-393, 64980-642, 62135-826, 62135-827, 53489-176, 53489-177, 69097-142, 68999-189, 0054-0742, 59651-183, 59651-184, 47335-703, 76204-027, 62135-828, 70752-102, 0781-7296 +2 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL, RESPIRATORY (INHALATION)
- Substance name
- ALBUTEROL SULFATE
- RxCUI
- 755497, 2123111, 197316, 197318, 801092, 801095, 859088, 2123076, 630208, 351136, 351137, 2123072, 245314
- SPL ID
- 316befe4-1351-2acb-e063-6394a90a9a17, 5242a3fe-0a61-251c-e063-6294a90ad050, fe7cbf82-9f32-327e-e053-6294a90aebc8, 08d3613c-b059-4e06-b42c-591a129f1649, 7d4c1e96-c05f-4ffc-80b6-988986a061bc, 94ad4684-ceb9-4c5e-9635-a6edb5904ccc, 1d6bfa3d-ae1f-8167-e063-6394a90a2356, 0ce1f4c5-3283-4e4d-a107-d82c8e78ee84, ca017981-2752-46e0-9a66-418535597d31, 881ca107-7a62-40e0-8936-89bc2d16cfa6, 54eddfbb-f919-1e84-e063-6294a90add14, 70817038-c7c0-4978-b5a2-0f6a0267ae33, 4ecf4a2e-bc85-7019-e063-6394a90a3202, 4ffe0388-e743-7259-e063-6394a90a94d2, aabe1b11-7f84-4db3-9d05-0c79a4a88ba2, 11e58070-ecf6-06b9-e063-6394a90adaba, 3449ab68-28d3-42f5-8d34-329bf6fa0e6b, 56c01144-7ba7-2f75-e063-6294a90a6e6f, 56c0a24f-4608-be23-e063-6294a90a9be2, 250b033d-3ed5-c0d1-e063-6394a90a93c9, 56c00cc1-5ed0-8ff5-e063-6394a90a132b, 11e59625-431b-e530-e063-6294a90a0596, 4d289f6d-634d-2125-e063-6394a90aa25d, 135ef57d-f447-45c6-ad56-e4f772dc98ee, 462ca25f-d461-c069-e063-6394a90a528a, 07a1b9ad-58cb-4c21-b8df-6854da990f85, 1e853c87-b534-65d2-e063-6394a90a7923, e48295e4-b6c1-434a-aa5f-25d900f1f16a, 4e7f86ab-55bc-c123-e063-6394a90abd8d, 11e5a7ae-f1eb-ea1f-e063-6294a90a0efb, f8b35fdc-741f-4ebd-91d5-a55a7ef8e261, 44ec30c6-e178-d2ed-e063-6394a90a25a5, 4ffd498d-4575-dd61-e063-6394a90a95d6
- SPL set ID
- 560df50c-e2c4-459f-9d89-bf7e6588949e, b0a5da99-6553-4088-ae27-7fa194438340, 81cdae6f-99d7-468b-9ab8-fecb1d42298d, d92c5d6b-ff10-4087-36a2-1cfc464cb967, fd0389e0-3713-42e0-8ef2-3bb97676fded, 5329614f-ae0b-4854-bb6f-ea0b7dae87c0, 1d6be2b8-c670-b783-e063-6294a90ae503, 489201d2-9ed0-419b-81dc-a7f7f86b59ed, 973b8686-c6ce-4280-85c4-c1e7ceab3c09, 2e449282-ee58-4e36-b983-85c4e6f0864d, 4aec7f59-b429-4b0e-a779-8df1dd8f80d7, b25d9d6b-eb4c-452e-89ef-10e611deebd6, 285a656c-f77f-4e77-b0a8-a0e9c901803f, b72742df-1a6b-4483-aff3-3e79db5e015d, 17858afa-dcdf-4612-b475-3b6baadfb639, 7f261a9b-65d9-408a-8609-c1b3809b8b4b, 29e35e54-dbd6-4426-993f-893d7a4d69be, 32377c09-da6d-331c-e063-6294a90a7a46, 32474c0e-af35-69d1-e063-6394a90a53c6, e14f5fd6-d01a-489d-9baa-61778b1352a8, 3236f82c-14e9-dfd4-e063-6294a90ac43d, 4e48ccbe-3ec0-4bf2-be28-83eb9baa63d6, 87b8cd3c-2849-4b50-b63e-9ea379165c07, c4d6d76a-14b8-411a-8019-e2c923c2c532, dd47559a-84f6-42a5-a00e-48754505418e, 6c64ab5d-f8a2-440a-a929-cb8188d0e8b4, 78e6bee2-7113-46cf-8c97-dc61b0f7b94f, bb538b7d-e390-419a-9404-a57c1db4a447, fdb4ac5a-bf0d-4896-89f7-1828c081b79e, 922bf33b-4d55-4c35-9f68-72efbb17c14f, 99a490cc-e41d-436b-9cf3-8facb7ac714f, f8a2c4b7-a162-48ab-90b0-350e4da25c66, d4c532be-1f41-60d3-e053-2995a90a98be
- Package NDC
- 62135-189-41, 62135-189-47, 62135-189-05, 62135-189-24, 62135-189-20, 62135-189-23, 60687-662-91, 62135-671-90, 62135-672-90, 0173-0682-20, 0173-0682-24, 69097-021-60, 0378-8270-62, 0378-8270-52, 0378-8270-93, 0378-8270-64, 0378-8270-91, 0378-8270-31, 0378-8270-55, 81894-105-25, 81894-105-30, 81894-106-25, 81894-106-30, 45802-088-01, 68180-963-01, 69238-1291-1, 60687-395-79, 60687-395-83, 66993-019-68, 0487-9904-25, 0487-9904-01, 0487-9904-02, 0487-0301-01, 0487-0301-02, 76204-200-25, 76204-200-30, 76204-200-60, 76204-200-01, 17270-0740-0, 62135-829-84 +49 more
- UNII
- 021SEF3731
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260911