Home NDC 42385-991-68 Valsartan
Product NDC 42385-991
Requested package NDC 42385-991-68
11-digit product format 423850991
Labeler code 42385
Product ID 42385-991_6e1f63ad-e554-421b-a699-4e8c9bd4d239
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Laurus Labs Limited
Application ANDA218897
Marketing category ANDA
Marketing start 2026-04-22
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 2027-12-31
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 A218897-001 VALSARTAN VALSARTAN 40MG TABLET / ORAL AB 2026-04-21 A218897-002 VALSARTAN VALSARTAN 80MG TABLET / ORAL AB 2026-04-21 A218897-003 VALSARTAN VALSARTAN 160MG TABLET / ORAL AB 2026-04-21 A218897-004 VALSARTAN VALSARTAN 320MG TABLET / ORAL AB 2026-04-21
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.
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218897-001 VALSARTAN 40MG TABLET / ORAL AB 2026-04-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218897-002 VALSARTAN 80MG TABLET / ORAL AB 2026-04-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218897-003 VALSARTAN 160MG TABLET / ORAL AB 2026-04-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218897-004 VALSARTAN 320MG TABLET / ORAL AB 2026-04-21 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218897-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218897-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218897-003 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218897-004 AB 1 a50c72e98297…
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 42385-991-05 Valsartan 500 in 1 BOTTLE TABLET, FILM COATED 500 1 42385-991-10 Valsartan 10 in 1 BLISTER PACK TABLET, FILM COATED 10 1 42385-991-30 Valsartan 30 in 1 BOTTLE TABLET, FILM COATED 30 1 42385-991-68 Valsartan 10 in 1 CARTON TABLET, FILM COATED 10 1 42385-991-90 Valsartan 90 in 1 BOTTLE TABLET, FILM COATED 90 1
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 42385-991-68 42385099168 10 BLISTER PACK in 1 CARTON (42385-991-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-991-10) 10 blister pack 2026-04-22 No No Current