Home NDC 0713-0870-30 Azor
Product NDC 0713-0870
Requested package NDC 0713-0870-30
11-digit product format 007130870
Labeler code 0713
Product ID 0713-0870_00491aef-cf0c-eeb3-e063-6394a90a716d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name amlodipine besylate and olmesartan medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cosette Pharmaceuticals, Inc.
Application NDA022100
Marketing category NDA
Marketing start 2022-09-01
Substance AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength 5; 20 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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.
Product history page 1 of 5 · 172 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 2026-09-14 22:38:34 2026-08 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022100-001 AZOR EQ 5MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022100-002 AZOR EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2007-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022100-003 AZOR EQ 10MG BASE;20MG TABLET / ORAL AB RLD 2007-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022100-004 AZOR EQ 10MG BASE;40MG TABLET / ORAL AB RLD, RS 2007-09-26 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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 Azor
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 5 mg/1 OLMESARTAN MEDOXOMIL 20 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 · 8 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 744624 Internal RxNorm lookup 744628 Internal RxNorm lookup 744632 Internal RxNorm lookup 744636 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0713-0870-30 Azor 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0870 AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [COSETTE PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20230713_c5535406-b63b-49aa-88b9-169aaf0ed08e.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 · 2 matching rows.
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 0713-0870-30 00713087030 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0870-30) 2022-09-01 0000-00-00 No No Current