Home NDC 70518-4577-0 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product NDC 70518-4577
Requested package NDC 70518-4577-0
11-digit product format 705184577
Labeler code 70518
Product ID 70518-4577_5efdfc0d-d152-6a2e-e063-6294a90a91d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA207037
Marketing category ANDA
Marketing start 2026-02-27
Substance OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
Active strength 40; 25 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 45 .
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 A207037-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2024-07-11 A207037-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2024-07-11 A207037-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2024-07-11
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.
Product history page 1 of 2 · 48 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 2026-11-14 07:37:17 2026-10 A207037-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2024-07-11 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A207037-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2024-07-11 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A207037-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2024-07-11 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A207037-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2024-07-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A207037-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2024-07-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A207037-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2024-07-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A207037-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2024-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207037-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2024-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207037-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2024-07-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207037-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2024-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207037-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2024-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207037-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2024-07-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207037-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2024-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207037-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2024-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207037-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2024-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207037-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2024-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207037-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2024-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207037-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2024-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207037-001 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2024-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207037-002 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2024-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207037-003 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2024-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207037-001 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2024-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207037-002 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2024-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207037-003 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2024-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207037-001 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2024-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207037-002 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2024-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207037-003 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2024-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207037-001 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2024-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207037-002 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2024-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207037-003 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2024-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207037-001 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2024-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207037-002 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2024-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207037-003 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2024-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207037-001 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2024-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207037-002 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2024-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207037-003 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2024-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207037-001 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2024-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207037-002 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2024-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207037-003 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2024-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207037-001 HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2024-07-11 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 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 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLMESARTAN MEDOXOMIL 40 mg/1 HYDROCHLOROTHIAZIDE 25 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 70518-4577-0 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70518-4577-0 70518457700 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4577-0) 2026-02-27 No No Current