Home NDC 50228-133-10 Valsartan
Product NDC 50228-133
Requested package NDC 50228-133-10
11-digit product format 502280133
Labeler code 50228
Product ID 50228-133_f1da8d58-f8d8-3616-e053-2995a90a27ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET
Route ORAL
Labeler ScieGen Pharmaceuticals, INC.
Application ANDA204038
Marketing category ANDA
Marketing start 2021-10-27
Substance VALSARTAN
Active strength 160 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 1 .
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 A204038-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL AB 2021-10-27 A204038-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL AB 2021-10-27 A204038-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL AB 2021-10-27 A204038-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL AB 2021-10-27
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 4 · 132 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 2026-02-19 14:30 UTC 2026-02 A204038-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204038-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204038-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204038-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204038-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204038-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204038-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204038-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204038-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204038-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204038-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204038-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204038-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204038-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204038-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204038-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204038-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204038-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204038-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204038-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204038-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204038-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204038-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204038-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204038-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204038-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204038-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204038-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204038-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204038-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204038-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204038-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204038-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204038-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204038-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204038-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204038-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204038-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204038-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204038-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-27 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Valsartan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALSARTAN 160 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 50228-133-10 Valsartan 1000 in 1 BOTTLE TABLET 1000 2 50228-133-30 Valsartan 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50228-133 VALSARTAN TABLET [SCIEGEN PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20230110_1a8af3d9-4053-4233-82a7-e8c7bc9e302f.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 Marketing end Sample Exclude flag Status 50228-133-10 50228013310 1000 TABLET in 1 BOTTLE (50228-133-10) 1000 tablet 2021-10-27 0000-00-00 No No Current