Home NDC 55111-734 Valsartan
Product NDC 55111-734
11-digit product format 551110734
Labeler code 55111
Product ID 55111-734_f7d1bd41-da10-005a-6e30-8a816db87867
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA201618
Marketing category ANDA
Marketing start 2018-01-19
Substance VALSARTAN
Active strength 320 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 A201618-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL AB 2021-10-05 A201618-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL AB 2021-10-05 A201618-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL AB 2021-10-05 A201618-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL AB 2021-10-05
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 4 · 136 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 A201618-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201618-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201618-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201618-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201618-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201618-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201618-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201618-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201618-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201618-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201618-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201618-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201618-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201618-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201618-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201618-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201618-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201618-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201618-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201618-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201618-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201618-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201618-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201618-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201618-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201618-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201618-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201618-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201618-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201618-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201618-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201618-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201618-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201618-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201618-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201618-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201618-001 VALSARTAN 40MG TABLET / ORAL AB 2021-10-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201618-002 VALSARTAN 80MG TABLET / ORAL AB 2021-10-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201618-003 VALSARTAN 160MG TABLET / ORAL AB 2021-10-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201618-004 VALSARTAN 320MG TABLET / ORAL AB 2021-10-05 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 136 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 320 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 55111-734-01 Valsartan 100 in 1 BOTTLE TABLET, FILM COATED 100 19 55111-734-05 Valsartan 500 in 1 BOTTLE TABLET, FILM COATED 500 19 55111-734-30 Valsartan 30 in 1 BOTTLE TABLET, FILM COATED 30 19 55111-734-60 Valsartan 60 in 1 BOTTLE TABLET, FILM COATED 60 19 55111-734-90 Valsartan 90 in 1 BOTTLE TABLET, FILM COATED 90 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-734 VALSARTAN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ] 18 Current NDC, Legacy NDC, 5 package rows 20221203_75235313-8a07-8849-9b5a-12887992033e.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Valsartan VALSARTAN Dr. Reddy's Laboratories Limited 75235313-8a07-8849-9b5a-12887992033e 2025-08-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201618 application number: ANDA201618 ndc (product): 55111-734
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 55111-734-01 55111073401 100 TABLET, FILM COATED in 1 BOTTLE (55111-734-01) 2021-10-05 0000-00-00 No No Current 55111-734-05 55111073405 500 TABLET, FILM COATED in 1 BOTTLE (55111-734-05) 2021-10-05 0000-00-00 No No Current 55111-734-30 55111073430 30 TABLET, FILM COATED in 1 BOTTLE (55111-734-30) 2021-10-05 0000-00-00 No No Current 55111-734-60 55111073460 60 TABLET, FILM COATED in 1 BOTTLE (55111-734-60) 2021-10-05 0000-00-00 No No Current 55111-734-90 55111073490 90 TABLET, FILM COATED in 1 BOTTLE (55111-734-90) 2021-10-05 0000-00-00 No No Current