NDC directory

Sacubitril and Valsartan

Aurobindo Pharma Limited · TABLET, FILM COATED

84386-081ANDAAngiotensin 2 Receptor Antagonists [MoA]
Product NDC
84386-081
Generic name
Sacubitril and Valsartan
Labeler name
Aurobindo Pharma Limited
Brand name
Sacubitril and Valsartan
Finished
true
Listing expiration date
20271231
Marketing category
ANDA
Dosage form
TABLET, FILM COATED
SPL ID
ccfa182e-8a23-42e1-9062-be2655c96208
Product type
HUMAN PRESCRIPTION DRUG
Marketing start date
20261026
Product ID
84386-081_ccfa182e-8a23-42e1-9062-be2655c96208
Application number
ANDA213631
Brand name base
Sacubitril and Valsartan
Active ingredients
  1. Name
    SACUBITRIL
    Strength
    24 mg/1
  2. Name
    VALSARTAN
    Strength
    26 mg/1
Packaging
  1. Package NDC
    84386-081-18
    Description
    180 TABLET, FILM COATED in 1 BOTTLE (84386-081-18)
    Marketing start date
    20261026
    Sample
    false
  2. Package NDC
    84386-081-60
    Description
    60 TABLET, FILM COATED in 1 BOTTLE (84386-081-60)
    Marketing start date
    20261026
    Sample
    false
  3. Package NDC
    84386-081-78
    Description
    10 BLISTER PACK in 1 CARTON (84386-081-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (84386-081-10)
    Marketing start date
    20261026
    Sample
    false
Route
ORAL
Pharm class
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]
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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.