Home NDC 72205-147-99 olmesartan medoxomil-hydrochlorothiazide
Product NDC 72205-147
Requested package NDC 72205-147-99
11-digit product format 722050147
Labeler code 72205
Product ID 72205-147_c8197eea-e990-4c0e-bc2d-f080bac8de17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olmesartan medoxomil-hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA217398
Marketing category ANDA
Marketing start 2025-09-26
Substance OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength 20; 12.5 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217398-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2025-09-26 A217398-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2025-09-26 A217398-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2025-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 A217398-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2025-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217398-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2025-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217398-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2025-09-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217398-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2025-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217398-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2025-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217398-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2025-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217398-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2025-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217398-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2025-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217398-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2025-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217398-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2025-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217398-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2025-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217398-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2025-09-26 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217398-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2025-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217398-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2025-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217398-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2025-09-26 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-hydrochlorothiazide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLMESARTAN MEDOXOMIL 20 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M97XTV3HD Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403853 Internal RxNorm lookup 403854 Internal RxNorm lookup 403855 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 72205-147-30 olmesartan medoxomil-hydrochlorothiazide 30 in 1 BOTTLE TABLET, FILM COATED 30 1 72205-147-90 olmesartan medoxomil-hydrochlorothiazide 90 in 1 BOTTLE TABLET, FILM COATED 90 1 72205-147-99 olmesartan medoxomil-hydrochlorothiazide 1000 in 1 BOTTLE TABLET, FILM COATED 1000 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 Marketing start Sample Exclude flag Status 72205-147-99 72205014799 1000 TABLET, FILM COATED in 1 BOTTLE (72205-147-99) 2025-09-30 No No Current