Home NDC 70518-4754-0 Olmesartan medoxomil and hydrochlorothiazide
Product NDC 70518-4754
Requested package NDC 70518-4754-0
11-digit product format 705184754
Labeler code 70518
Product ID 70518-4754_5b8b6d38-62ce-f692-e063-6394a90aa2ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olmesartan medoxomil and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA209199
Marketing category ANDA
Marketing start 2026-09-15
Substance OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength 40; 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 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209199-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2025-07-25 A209199-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2025-07-25 A209199-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2025-07-25
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 A209199-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2025-07-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209199-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2025-07-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209199-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2025-07-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209199-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2025-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209199-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2025-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209199-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2025-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209199-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2025-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209199-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2025-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209199-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2025-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209199-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2025-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209199-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2025-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209199-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2025-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209199-001 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2025-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209199-002 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2025-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209199-003 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2025-07-25 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209199-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2025-07-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209199-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2025-07-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209199-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2025-07-25 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 and hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLMESARTAN MEDOXOMIL 40 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70518-4754-0 70518475400 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4754-0) 2026-09-15 No No Current