Home NDC 13668-385 Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg
Product NDC 13668-385
11-digit product format 136680385
Labeler code 13668
Product ID 13668-385_ef5817f9-89bf-2fd7-e053-2a95a90a65b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA203580
Marketing category ANDA
Marketing start 2016-10-26
Marketing end 0000-00-00
Substance AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength 5 mg/1; mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 13668-385-30 excluded package package 13668-385-05 excluded package package 13668-385-90
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203580-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2016-10-26 A203580-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 A203580-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 A203580-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 A203580-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 220 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 2026-10-15 13:18:30 2026-09 A203580-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2016-10-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203580-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203580-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203580-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203580-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203580-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2016-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203580-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203580-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203580-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203580-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203580-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL 2016-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203580-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203580-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203580-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL 2016-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203580-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL 2016-10-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203580-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL 2016-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203580-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203580-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203580-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL 2016-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203580-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL 2016-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203580-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL 2016-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203580-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203580-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203580-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL 2016-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203580-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL 2016-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203580-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL 2016-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203580-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203580-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203580-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL 2016-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203580-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL 2016-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203580-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2016-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203580-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203580-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203580-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203580-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203580-001 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB 2016-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203580-002 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203580-003 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203580-004 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB 2016-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203580-005 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;40MG TABLET / ORAL AB 2016-10-26 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 6 of 6 · 205 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203580-003 AB 1 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203580-004 AB 1 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203580-005 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203580-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203580-003 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-385 OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 20/5/12.5 MG (OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 20/5/12.5 MG) TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/5/12.5 MG (OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/5/12.5 MG) TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/5/25 MG (OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/5/25 MG) TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/10/12.5 MG (OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/10/12.5 MG) TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/10/25 MG (OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/10/25 MG) TABLET [TORRENT PHARMACEUTICALS LIMITED] 11 Legacy NDC 20241213_85b8f9c6-aa53-4aa1-85d6-19f823d0d252.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13668-385-05 13668038505 500 TABLET in 1 BOTTLE (13668-385-05) 500 tablet 2016-10-26 0000-00-00 No No Current 13668-385-30 13668038530 30 TABLET in 1 BOTTLE (13668-385-30) 30 tablet 2016-10-26 0000-00-00 No No Current 13668-385-74 13668038574 100 TABLET in 1 CARTON (13668-385-74) 100 tablet 2016-10-26 0000-00-00 No No Current 13668-385-90 13668038590 90 TABLET in 1 BOTTLE (13668-385-90) 90 tablet 2016-10-26 0000-00-00 No No Current