Home NDC 57664-774-99 Amlodipine and Olmesartan Medoxomil
Product NDC 57664-774
Requested package NDC 57664-774-99
11-digit product format 576640774
Labeler code 57664
Product ID 57664-774_439ecdf0-8908-4f16-a2e9-c13e17a51e43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate and olmesartan medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA022100
Marketing category NDA
Marketing start 2016-10-26
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength 5 mg/1; mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 N022100-001 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 N022100-002 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 N022100-003 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 N022100-004 AZOR AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26
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 2026-08-01 22:54:32 2026-06 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57664-774-99 57664077499 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-774-99) 2016-10-26 0000-00-00 No No Current