Home NDC 60290-086-02 Sacubitril and Valsartan
Product NDC 60290-086
Requested package NDC 60290-086-02
11-digit product format 602900086
Labeler code 60290
Product ID 60290-086_58755781-9a9f-4ab3-e063-6294a90aa226
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 49; 51 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 43 .
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 2026-09-14 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 49 mg/1 VALSARTAN 51 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 80M03YXJ7I Internal UNII lookup 17ERJ0MKGI 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.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels 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 60290-086-02 60290008602 180 TABLET, FILM COATED in 1 BOTTLE (60290-086-02) 2026-08-10 No No Current