Application 021162

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	TABLET;ORAL	12.5MG;40MG	Yes	No
002	MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	TABLET;ORAL	12.5MG;80MG	Yes	No
003	MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	TABLET;ORAL	25MG;80MG	Yes	Yes

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
N021162-001	MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17
N021162-002	MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17
N021162-003	MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021162-001	AB
N021162-002	AB
N021162-003	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 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	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021162-002	MICARDIS HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	2000-11-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021162-003	MICARDIS HCT	25MG;80MG	TABLET / ORAL	AB	RLD, RS	2004-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021162-001	MICARDIS HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2000-11-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021162-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021162-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021162-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021162-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021162-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021162-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021162-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021162-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021162-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021162-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021162-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021162-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021162-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021162-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021162-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021162-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021162-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021162-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021162-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021162-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021162-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021162-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021162-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021162-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021162-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021162-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021162-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021162-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021162-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021162-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021162-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021162-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021162-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021162-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021162-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021162-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021162-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021162-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021162-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021162-001	AB	1	`301d65b070ca…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021162-001	6358986	2020-01-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021162-002	6358986	2020-01-10	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021162-001	6358986	2020-01-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021162-002	6358986	2020-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021162-001	6358986	2020-01-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021162-002	6358986	2020-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021162-001	6358986	2020-01-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021162-002	6358986	2020-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021162-001	6358986	2020-01-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021162-002	6358986	2020-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021162-001	6358986	2020-01-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021162-002	6358986	2020-01-10	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Micardis HCT	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Boehringer Ingelheim Pharmaceuticals, Inc.	b078dae2-664d-4144-847a-3b9d9b557402	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021162 application number: NDA021162 ndc (product): 0597-0044 ndc (product): 0597-0043 ndc (product): 0597-0042

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0545	telmisartan and hydrochlorothiazide	telmisartan and hydrochlorothiazide	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0054-0545	telmisartan and hydrochlorothiazide	telmisartan and hydrochlorothiazide	Hikma Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
0054-0545	telmisartan and hydrochlorothiazide	telmisartan and hydrochlorothiazide	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0054-0546	telmisartan and hydrochlorothiazide	telmisartan and hydrochlorothiazide	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0054-0546	telmisartan and hydrochlorothiazide	telmisartan and hydrochlorothiazide	Hikma Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
0054-0546	telmisartan and hydrochlorothiazide	telmisartan and hydrochlorothiazide	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0054-0547	telmisartan and hydrochlorothiazide	telmisartan and hydrochlorothiazide	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0054-0547	telmisartan and hydrochlorothiazide	telmisartan and hydrochlorothiazide	Hikma Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
0054-0547	telmisartan and hydrochlorothiazide	telmisartan and hydrochlorothiazide	West-Ward Pharmaceuticals Corp.	NDA AUTHORIZED GENERIC	Current
0597-0042	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0042	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0042	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0042	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0043	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0043	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0043	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0043	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0044	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0044	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0044	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0044	Micardis HCT	telmisartan and hydrochlorothiazide	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72985	SUPPL	2022-12-21
72976	SUPPL	2022-12-21
64355	SUPPL	2020-08-21
64340	SUPPL	2020-08-21
52299	SUPPL	2018-02-02
52261	SUPPL	2018-02-02
36249	SUPPL	2016-01-25
26946	SUPPL	2016-01-14
36250	SUPPL	2014-12-16
26947	SUPPL	2014-12-15
14538	SUPPL	2012-11-07
4511	SUPPL	2012-10-26
14537	SUPPL	2012-01-23
14535	SUPPL	2012-01-23
4510	SUPPL	2012-01-23
4509	SUPPL	2012-01-23
23630	ORIG	2011-12-22
36248	SUPPL	2011-05-27
14536	SUPPL	2011-05-27
26945	SUPPL	2011-05-06
26944	SUPPL	2011-05-06
26943	SUPPL	2009-11-25
4508	SUPPL	2009-11-25
36247	SUPPL	2009-09-17
14534	SUPPL	2009-09-17
4507	SUPPL	2007-03-06
36246	SUPPL	2005-09-08
26942	SUPPL	2005-09-08
26941	SUPPL	2004-04-29
41996	ORIG	2004-03-11
36245	ORIG	2000-11-17
26940	ORIG	2000-11-17