Home NDC 71209-023-04 AMLODIPINE AND VALSARTAN
Product NDC 71209-023
Requested package NDC 71209-023-04
11-digit product format 712090023
Labeler code 71209
Product ID 71209-023_5ea0b9e9-1f6c-49a9-a5db-e50da5721e60
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine and valsartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cadila Pharmaceuticals Limited
Application ANDA205797
Marketing category ANDA
Marketing start 2026-10-22
Substance AMLODIPINE BESYLATE; VALSARTAN
Active strength 5; 320 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
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 45 .
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 A205797-001 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2026-10-21 A205797-002 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2026-10-21 A205797-003 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2026-10-21 A205797-004 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2026-10-21
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 2026-11-14 07:37:17 2026-10 A205797-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2026-10-21 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A205797-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2026-10-21 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A205797-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2026-10-21 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A205797-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2026-10-21 d4dbc9d85df4…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base AMLODIPINE AND VALSARTAN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 5 mg/1 VALSARTAN 320 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864V2Q084H Internal UNII lookup 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 722126 Internal RxNorm lookup 722131 Internal RxNorm lookup 722134 Internal RxNorm lookup 722137 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71209-023-04 71209002304 90 TABLET, FILM COATED in 1 BOTTLE (71209-023-04) 2026-10-22 No No Current