Home NDC 31722-894 Olmesartan medoxomil, amlodipine and hydrochlorothiazide
Product NDC 31722-894
11-digit product format 317220894
Labeler code 31722
Product ID 31722-894_47b1c419-e608-66b1-e063-6394a90ae253
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olmesartan medoxomil, amlodipine and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA209242
Marketing category ANDA
Marketing start 2025-10-06
Substance OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Active strength 40; 5; 25 mg/1; 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], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [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 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209242-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-10-06 A209242-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 A209242-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06 A209242-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 A209242-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 2026-09-14 22:38:34 2026-08 A209242-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209242-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209242-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209242-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209242-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209242-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209242-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209242-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209242-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209242-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209242-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209242-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209242-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209242-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209242-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209242-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209242-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209242-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209242-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209242-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209242-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2025-10-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209242-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209242-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209242-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2025-10-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209242-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2025-10-06 a50c72e98297…
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 Olmesartan medoxomil, amlodipine and hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLMESARTAN MEDOXOMIL 40 mg/1 AMLODIPINE BESYLATE 5 mg/1 HYDROCHLOROTHIAZIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864V2Q084H Internal UNII lookup 6M97XTV3HD Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 999967 Internal RxNorm lookup 999986 Internal RxNorm lookup 999991 Internal RxNorm lookup 999996 Internal RxNorm lookup 1000001 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 31722-894-30 Olmesartan medoxomil, amlodipine and hydrochlorothiazide 30 in 1 BOTTLE TABLET, FILM COATED 30 1 31722-894-31 Olmesartan medoxomil, amlodipine and hydrochlorothiazide 10 in 1 BLISTER PACK TABLET, FILM COATED 10 1 31722-894-32 Olmesartan medoxomil, amlodipine and hydrochlorothiazide 10 in 1 CARTON TABLET, FILM COATED 10 1 31722-894-90 Olmesartan medoxomil, amlodipine and hydrochlorothiazide 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 31722-894-30 31722089430 30 TABLET, FILM COATED in 1 BOTTLE (31722-894-30) 2025-10-06 No No Current 31722-894-31 31722089431 10 in 1 BLISTER PACK Historical 31722-894-32 31722089432 10 BLISTER PACK in 1 CARTON (31722-894-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-894-31) 10 blister pack 2025-10-06 No No Current 31722-894-90 31722089490 90 TABLET, FILM COATED in 1 BOTTLE (31722-894-90) 2025-10-06 No No Current