Home NDC 70954-310 Valsartan
Product NDC 70954-310
11-digit product format 709540310
Labeler code 70954
Product ID 70954-310_12e344cb-87c4-44a1-a59a-c6bcaaa6cb2c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form SOLUTION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA214102
Marketing category ANDA
Marketing start 2021-11-02
Substance VALSARTAN
Active strength 4 mg/mL
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214102-001 VALSARTAN VALSARTAN 4MG/ML SOLUTION / ORAL AB RS 2021-11-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214102-001 AB
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 2026-08-18 06:07:40 2026-07 A214102-001 VALSARTAN 4MG/ML SOLUTION / ORAL AB RS 2021-11-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214102-001 VALSARTAN 4MG/ML SOLUTION / ORAL AB RS 2021-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214102-001 VALSARTAN 4MG/ML SOLUTION / ORAL AB RS 2021-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214102-001 VALSARTAN 4MG/ML SOLUTION / ORAL AB RS 2021-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL 2021-11-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL 2021-11-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL 2021-11-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL 2021-11-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL 2021-11-02 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL RS 2021-11-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL 2021-11-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL 2021-11-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL 2021-11-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL 2021-11-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214102-001 VALSARTAN 20MG/5ML SOLUTION / ORAL 2021-11-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214102-001 VALSARTAN 4MG/ML SOLUTION / ORAL AB RS 2021-11-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Valsartan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALSARTAN 4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 80M03YXJ7I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1996254 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 70954-310-10 Valsartan 120 mL in 1 BOTTLE, PLASTIC SOLUTION 120 3 70954-310-20 Valsartan 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-310 VALSARTAN SOLUTION [ANI PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20230919_959b6790-feb7-45a9-9ea4-0ee1a7fce048.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70954-310-10 70954031010 120 mL in 1 BOTTLE, PLASTIC (70954-310-10) 120 ml 2021-11-02 0000-00-00 No No Current 70954-310-20 70954031020 473 mL in 1 BOTTLE, PLASTIC (70954-310-20) 473 ml 2021-11-02 0000-00-00 No No Current