Home NDC 60290-085 Sacubitril and Valsartan
Product NDC 60290-085
11-digit product format 602900085
Labeler code 60290
Product ID 60290-085_5e7d3d19-371a-af31-e063-6394a90a4168
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sacubitril and Valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Umedica Laboratories USA Inc.
Application ANDA219946
Marketing category ANDA
Marketing start 2026-08-10
Substance SACUBITRIL; VALSARTAN
Active strength 24; 26 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219946-001 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 24MG;26MG TABLET / ORAL AB 2026-08-04 A219946-002 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 49MG;51MG TABLET / ORAL AB 2026-08-04 A219946-003 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 97MG;103MG TABLET / ORAL AB 2026-08-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A219946-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2026-08-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219946-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2026-08-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219946-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2026-08-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219946-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2026-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219946-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2026-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219946-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2026-08-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219946-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2026-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219946-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2026-08-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219946-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2026-08-04 caaa826d4ba7…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sacubitril and Valsartan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SACUBITRIL 24 mg/1 VALSARTAN 26 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60290-085-01 60290008501 60 TABLET, FILM COATED in 1 BOTTLE (60290-085-01) 2026-08-10 No No Current 60290-085-02 60290008502 180 TABLET, FILM COATED in 1 BOTTLE (60290-085-02) 2026-08-10 No No Current 60290-085-03 60290008503 1000 TABLET, FILM COATED in 1 BOTTLE (60290-085-03) 2026-08-10 No No Current