Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 20/5/12.5 mg

Product NDC: 13668-397
11-digit product format: 136680397
Labeler code: 13668
Product ID: 13668-397_ef5817f9-89bf-2fd7-e053-2a95a90a65b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 20/5/12.5 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13668-397		D	Discontinued by firm	2026-10-15
excluded package	package	13668-397	13668-397-05	D	Discontinued by firm	2026-10-15
excluded package	package	13668-397	13668-397-30	D	Discontinued by firm	2026-10-15
excluded package	package	13668-397	13668-397-90	D	Discontinued by firm	2026-10-15

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	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.

Application-product, TE code table
Application-product	TE code
A203580-001	AB
A203580-002	AB
A203580-003	AB
A203580-004	AB
A203580-005	AB

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	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-397-30	EA - Each	13668-397	61231524-8dca-498d-ae09-0ed5680c9250	1	2018-03-08
13668-397-90	EA - Each	13668-397	989b0488-2908-4adc-b064-ae93316ae4ab	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-397	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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1J444QC288	AMLODIPINE	88150-42-9	AMLODIPINE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
6M97XTV3HD	OLMESARTAN MEDOXOMIL	144689-63-4	OLMESARTAN MEDOXOMIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-397-05	13668039705	500 TABLET in 1 BOTTLE (13668-397-05)	500 tablet	2016-10-26	0000-00-00	No	No	Current
13668-397-30	13668039730	30 TABLET in 1 BOTTLE (13668-397-30)	30 tablet	2016-10-26	0000-00-00	No	No	Current
13668-397-74	13668039774	100 TABLET in 1 BOTTLE (13668-397-74)	100 tablet	2016-10-26	0000-00-00	No	No	Current
13668-397-90	13668039790	90 TABLET in 1 BOTTLE (13668-397-90)	90 tablet	2016-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 20/5/12.5 mg	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2025-07-17	HUMAN PRESCRIPTION DRUG LABEL	12