Home NDC 70377-033-11 Sacubitril and Valsartan
Product NDC 70377-033
Requested package NDC 70377-033-11
11-digit product format 703770033
Labeler code 70377
Product ID 70377-033_600f67e2-7ccf-65d9-012c-e7ba9b8a089f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sacubitril and Valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Biocon Pharma Inc.
Application ANDA213680
Marketing category ANDA
Marketing start 2025-07-17
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A213680-001 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 A213680-002 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 A213680-003 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30
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 2026-02-19 14:30 UTC 2026-02 A213680-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213680-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213680-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213680-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213680-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213680-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213680-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213680-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213680-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213680-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213680-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213680-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213680-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213680-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213680-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213680-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213680-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213680-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213680-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213680-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213680-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213680-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213680-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213680-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213680-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213680-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213680-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213680-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213680-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213680-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213680-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213680-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213680-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-30 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sacubitril and Valsartan
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70377-033-11 Sacubitril and Valsartan 30 in 1 BOTTLE TABLET, FILM COATED 30 5 70377-033-12 Sacubitril and Valsartan 60 in 1 BOTTLE TABLET, FILM COATED 60 5 70377-033-13 Sacubitril and Valsartan 180 in 1 BOTTLE TABLET, FILM COATED 180 5 70377-033-14 Sacubitril and Valsartan 500 in 1 BOTTLE TABLET, FILM COATED 500 5
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70377-033-11 70377003311 30 TABLET, FILM COATED in 1 BOTTLE (70377-033-11) 2025-07-17 No No Current