Home NDC 0378-5807 Valsartan
Product NDC 0378-5807
11-digit product format 003785807
Labeler code 0378
Product ID 0378-5807_a5384d58-48c7-494a-a8a8-c296b316bd91
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA090866
Marketing category ANDA
Marketing start 2015-01-05
Substance VALSARTAN
Active strength 40 mg/1
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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090866-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 A090866-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 A090866-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 A090866-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL AB 2015-01-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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.
Product history page 1 of 5 · 168 observed 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 A090866-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090866-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090866-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090866-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090866-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090866-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090866-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090866-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090866-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090866-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090866-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090866-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090866-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090866-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090866-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090866-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090866-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090866-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090866-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090866-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090866-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090866-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090866-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090866-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090866-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090866-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090866-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090866-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090866-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090866-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090866-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090866-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090866-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090866-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090866-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090866-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090866-001 VALSARTAN 40MG TABLET / ORAL AB 2015-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090866-002 VALSARTAN 80MG TABLET / ORAL AB 2015-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090866-003 VALSARTAN 160MG TABLET / ORAL AB 2015-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090866-004 VALSARTAN 320MG TABLET / ORAL AB 2015-01-05 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Valsartan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALSARTAN 40 mg/1
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349199 Internal RxNorm lookup 349200 Internal RxNorm lookup 349201 Internal RxNorm lookup 349483 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 0378-5807-93 Valsartan 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALSARTAN ACTIVE INGREDIENT 80M03YXJ7I VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 VALSARTAN ACTIVE MOIETY 80M03YXJ7I VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 POVIDONES INACTIVE INGREDIENT FZ989GH94E VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-5807 VALSARTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 15 Current NDC, Legacy NDC, 1 package rows 20240901_73e01dc6-7dd4-421a-a4f6-137e75f69f9a.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 Marketing start Marketing end Sample Exclude flag Status 0378-5807-93 00378580793 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5807-93) 2015-01-05 0000-00-00 No No Current