Home NDC 13668-634-60 sacubitril and valsartan
Product NDC 13668-634
Requested package NDC 13668-634-60
11-digit product format 136680634
Labeler code 13668
Product ID 13668-634_3876b6f1-ea3c-4aa1-a1ee-876e32efc629
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sacubitril and valsartan
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA213604
Marketing category ANDA
Marketing start 2025-07-16
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 13668-634 13668-634-60 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 13668-634 13668-634-60 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…
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 A213604-001 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 A213604-002 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 A213604-003 SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22
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 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL 2024-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL 2024-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL 2024-08-22 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213604-001 SACUBITRIL AND VALSARTAN 24MG;26MG TABLET / ORAL AB 2024-08-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213604-002 SACUBITRIL AND VALSARTAN 49MG;51MG TABLET / ORAL AB 2024-08-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213604-003 SACUBITRIL AND VALSARTAN 97MG;103MG TABLET / ORAL AB 2024-08-22 a50c72e98297…
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
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13668-634-05 sacubitril and valsartan 500 in 1 BOTTLE TABLET 500 12 13668-634-33 sacubitril and valsartan 180 in 1 BOTTLE TABLET 180 12 13668-634-60 sacubitril and valsartan 60 in 1 BOTTLE TABLET 60 12 13668-634-71 sacubitril and valsartan 10 in 1 BLISTER PACK TABLET 10 12 13668-634-74 sacubitril and valsartan 100 in 1 CARTON TABLET 100 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-634 SACUBITRIL AND VALSARTAN TABLET [TORRENT PHARMACEUTICALS LIMITED] 10 Current NDC, 5 package rows 20241211_59b7a07a-96ee-44b1-8dae-2b42169aa2c5.zip
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 Units Marketing start Sample Exclude flag Status 13668-634-60 13668063460 60 TABLET in 1 BOTTLE (13668-634-60) 60 tablet 2025-07-16 No No Current