Home NDC 60290-087 Sacubitril and Valsartan
Product NDC 60290-087
11-digit product format 602900087
Labeler code 60290
Product ID 60290-087_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 97; 103 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 45 .
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 2026-11-14 07:37:17 2026-10 A219946-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2026-08-04 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A219946-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2026-08-04 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A219946-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2026-08-04 d4dbc9d85df4…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 97 mg/1 VALSARTAN 103 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 17ERJ0MKGI Internal UNII lookup 80M03YXJ7I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1656340 Internal RxNorm lookup 1656349 Internal RxNorm lookup 1656354 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60290-087-01 60290008701 60 TABLET, FILM COATED in 1 BOTTLE (60290-087-01) 2026-08-10 No No Current 60290-087-02 60290008702 180 TABLET, FILM COATED in 1 BOTTLE (60290-087-02) 2026-08-10 No No Current 60290-087-03 60290008703 1000 TABLET, FILM COATED in 1 BOTTLE (60290-087-03) 2026-08-10 No No Current