Home NDC 13668-253 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product NDC 13668-253
11-digit product format 136680253
Labeler code 13668
Product ID 13668-253_0f14431f-59f1-4bac-a78c-55cd0147c727
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/25
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA206515
Marketing category ANDA
Marketing start 2017-04-24
Marketing end 0000-00-00
Substance HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength 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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;20MG TABLET / ORAL 2017-05-03 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 12.5MG;40MG TABLET / ORAL 2017-05-03 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL 25MG;40MG TABLET / ORAL 2017-05-03
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 4 · 129 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 2026-09-14 22:38:34 2026-08 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 63 observed states.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13668-253-01 13668025301 1000 TABLET in 1 BOTTLE (13668-253-01) 1000 tablet 2017-04-24 0000-00-00 No No Current 13668-253-30 13668025330 30 TABLET in 1 BOTTLE (13668-253-30) 30 tablet 2017-04-24 0000-00-00 No No Current 13668-253-74 13668025374 100 TABLET in 1 BOTTLE (13668-253-74) 100 tablet 2017-04-24 0000-00-00 No No Current 13668-253-90 13668025390 90 TABLET in 1 BOTTLE (13668-253-90) 90 tablet 2017-04-24 0000-00-00 No No Current