Home NDC 13668-252 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product NDC 13668-252
11-digit product format 136680252
Labeler code 13668
Product ID 13668-252_0f14431f-59f1-4bac-a78c-55cd0147c727
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5
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 13 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 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 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 2 of 4 · 132 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 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL 2017-05-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL 2017-05-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL 2017-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-05-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-05-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-05-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-05-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-05-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-05-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-05-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-05-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-05-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-05-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-05-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-05-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-05-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-05-03 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-05-03 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-05-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-05-03 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-05-03 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-05-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-05-03 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-05-03 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A206515-003 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 25MG;40MG TABLET / ORAL AB 2017-05-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206515-001 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;20MG TABLET / ORAL AB 2017-05-03 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A206515-002 OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2017-05-03 c0c555d07b60…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 63 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13668-252-01 13668025201 1000 TABLET in 1 BOTTLE (13668-252-01) 1000 tablet 2017-04-24 0000-00-00 No No Current 13668-252-30 13668025230 30 TABLET in 1 BOTTLE (13668-252-30) 30 tablet 2017-04-24 0000-00-00 No No Current 13668-252-74 13668025274 100 TABLET in 1 BOTTLE (13668-252-74) 100 tablet 2017-04-24 0000-00-00 No No Current 13668-252-90 13668025290 90 TABLET in 1 BOTTLE (13668-252-90) 90 tablet 2017-04-24 0000-00-00 No No Current