NDC directory

OZEMPIC

oral semaglutide · Novo Nordisk Pharmaceutical Industries, LP · TABLET

0169-1704NDAGLP-1 Receptor Agonist [EPC]
Open FDA's page for this record
Product NDC
0169-1704
Generic name
oral semaglutide
Labeler name
Novo Nordisk Pharmaceutical Industries, LP
Brand name
OZEMPIC
Finished
true
Listing expiration date
20271231
Marketing category
NDA
Dosage form
TABLET
SPL ID
6834044a-22f1-4f35-b846-b3448ee84c16
Product type
HUMAN PRESCRIPTION DRUG
Marketing start date
20260427
Product ID
0169-1704_6834044a-22f1-4f35-b846-b3448ee84c16
Application number
NDA213051
Brand name base
OZEMPIC
Active ingredients
  1. Name
    SEMAGLUTIDE
    Strength
    4 mg/1
Packaging
  1. Package NDC
    0169-1704-30
    Description
    30 TABLET in 1 BOTTLE, PLASTIC (0169-1704-30)
    Marketing start date
    20260427
    Sample
    false
Route
ORAL
Pharm class
GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
Harmonized identifiers (openFDA)
Manufacturer name
Novo Nordisk Pharmaceutical Industries, LP
RxCUI
2200644, 2200650, 2200652, 2200654, 2200656, 2200658, 2707547, 2707549, 2707551, 2707553, 2707555, 2707557, 2736944, 2736946, 2736948
SPL set ID
27f15fac-7d98-4114-a2ec-92494a91da98
Is original packager
true
Nui
N0000178480, M0160181, N0000020058
Pharm class epc
GLP-1 Receptor Agonist [EPC]
Pharm class cs
Glucagon-Like Peptide 1 [CS]
Pharm class moa
Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
UNII
53AXN4NNHX
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.