Home NDC 42571-205 OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE
Product NDC 42571-205
11-digit product format 425710205
Labeler code 42571
Product ID 42571-205_4f799eb1-290a-640c-e063-6294a90ac62b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olmesartan medoxomil and hydrocholorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Micro Labs Limited
Application ANDA206371
Marketing category ANDA
Marketing start 2026-10-15
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 44 .
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 A206371-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL AB 2026-04-13 A206371-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL AB 2026-04-13 A206371-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL AB 2026-04-13
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 2026-10-15 13:18:30 2026-09 A206371-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2026-04-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206371-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2026-04-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206371-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2026-04-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A206371-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2026-04-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206371-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2026-04-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206371-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2026-04-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206371-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2026-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206371-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2026-04-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206371-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2026-04-13 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206371-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2026-04-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206371-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2026-04-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206371-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2026-04-13 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 HYDROCHOLOROTHIAZIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLMESARTAN MEDOXOMIL 40 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42571-205-05 42571020505 500 TABLET, FILM COATED in 1 BOTTLE (42571-205-05) 2026-10-15 No No Current 42571-205-10 42571020510 1000 TABLET, FILM COATED in 1 BOTTLE (42571-205-10) 2026-10-15 No No Current 42571-205-30 42571020530 30 TABLET, FILM COATED in 1 BOTTLE (42571-205-30) 2026-10-15 No No Current 42571-205-90 42571020590 90 TABLET, FILM COATED in 1 BOTTLE (42571-205-90) 2026-10-15 No No Current