Home NDC 42291-004 Amlodipine and Olmesartan Medoxomil
Product NDC 42291-004
11-digit product format 422910004
Labeler code 42291
Product ID 42291-004_48480a71-5c94-91ab-e063-6294a90a656d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine and Olmesartan Medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA209010
Marketing category ANDA
Marketing start 2024-06-18
Substance AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength 10; 40 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 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 A209010-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2018-12-03 A209010-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2018-12-03 A209010-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2018-12-03 A209010-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2018-12-03
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 A209010-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2018-12-03 a50c72e98297…2026-08-01 22:54:32 2026-06 A209010-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2018-12-03 a50c72e98297…2026-08-01 22:54:32 2026-06 A209010-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2018-12-03 a50c72e98297…2026-08-01 22:54:32 2026-06 A209010-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2018-12-03 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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Amlodipine and Olmesartan Medoxomil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 10 mg/1 OLMESARTAN MEDOXOMIL 40 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 6M97XTV3HD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 730861 Internal RxNorm lookup 730866 Internal RxNorm lookup 730869 Internal RxNorm lookup 730872 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 42291-004-30 Amlodipine and Olmesartan Medoxomil 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [AVKARE] 2 Current NDC, 1 package rows 20240706_1b30c3fe-5c84-0d42-e063-6394a90a81d8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42291-004-30 42291000430 30 TABLET, FILM COATED in 1 BOTTLE (42291-004-30) 2024-06-18 No No Current