Micardis HCT

Product NDC: 0597-0044
11-digit product format: 005970044
Labeler code: 0597
Product ID: 0597-0044_ea1ff12a-df9e-477b-9e91-f89381987c6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: telmisartan and hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA021162
Marketing category: NDA
Marketing start: 2000-12-01
Substance: TELMISARTAN; HYDROCHLOROTHIAZIDE
Active strength: 80; 12.5 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: 2026-12-31
Current FDA listing: 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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Micardis HCT
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TELMISARTAN	80 mg/1
HYDROCHLOROTHIAZIDE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0J48LPH2TH	Internal UNII lookup
U5SYW473RQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283316	Internal RxNorm lookup
283317	Internal RxNorm lookup
477130	Internal RxNorm lookup
749833	Internal RxNorm lookup
749837	Internal RxNorm lookup
749841	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b078dae2-664d-4144-847a-3b9d9b557402	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
796916df-49fa-d043-64a7-fee11194676c	Product name	9	20171130
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0597-0044-37	Micardis HCT	10 in 1 BLISTER PACK	TABLET	10		26
0597-0044-37	Micardis HCT	3 in 1 CARTON	TABLET	3		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0044-37	EA - Each	0597-0044	bd7261cc-95ee-4f1f-9619-783cd52eb266	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	17
TELMISARTAN	ACTIVE INGREDIENT	U5SYW473RQ	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	17
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	17
TELMISARTAN	ACTIVE MOIETY	U5SYW473RQ	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	17
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TELMISARTAN	ACTIVE INGREDIENT	U5SYW473RQ	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TELMISARTAN	ACTIVE MOIETY	U5SYW473RQ	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0597-0044	MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	26	Current NDC, Legacy NDC, 2 package rows	20250327_b078dae2-664d-4144-847a-3b9d9b557402.zip

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U5SYW473RQ	TELMISARTAN	144701-48-4	TELMISARTAN
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
749833	Micardis HCT 40 MG /12.5 MG Oral Tablet	PSN	b078dae2-664d-4144-847a-3b9d9b557402	26
749837	Micardis-HCT 80 MG / 12.5 MG Oral Tablet	PSN	b078dae2-664d-4144-847a-3b9d9b557402	26
749841	Micardis-HCT 80 MG / 25 MG Oral Tablet	PSN	b078dae2-664d-4144-847a-3b9d9b557402	26
283316	telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	b078dae2-664d-4144-847a-3b9d9b557402	26
283317	telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	b078dae2-664d-4144-847a-3b9d9b557402	26
477130	telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	b078dae2-664d-4144-847a-3b9d9b557402	26
749833	hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral Tablet [Micardis-HCT]	SBD	b078dae2-664d-4144-847a-3b9d9b557402	26
749837	hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]	SBD	b078dae2-664d-4144-847a-3b9d9b557402	26
749841	hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]	SBD	b078dae2-664d-4144-847a-3b9d9b557402	26
283316	hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral Tablet	SCD	b078dae2-664d-4144-847a-3b9d9b557402	26
283317	hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral Tablet	SCD	b078dae2-664d-4144-847a-3b9d9b557402	26
477130	hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet	SCD	b078dae2-664d-4144-847a-3b9d9b557402	26
283316	HCTZ 12.5 MG / telmisartan 40 MG Oral Tablet	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
749833	HCTZ 12.5 MG / telmisartan 40 MG Oral Tablet [Micardis-HCT]	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
283317	HCTZ 12.5 MG / telmisartan 80 MG Oral Tablet	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
749837	HCTZ 12.5 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
477130	HCTZ 25 MG / telmisartan 80 MG Oral Tablet	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
749841	HCTZ 25 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
749833	Micardis-HCT 40/12.5 (telmisartan / hydrochlorothiazide) Oral Tablet	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
749833	Micardis-HCT 40/12.5 Oral Tablet	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
749837	Micardis-HCT 80/12.5 (telmisartan / hydrochlorothiazide) Oral Tablet	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
749837	Micardis-HCT 80/12.5 Oral Tablet	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
749841	Micardis-HCT 80/25 (telmisartan / hydrochlorothiazide) Oral Tablet	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
749841	Micardis-HCT 80/25 Oral Tablet	SY	b078dae2-664d-4144-847a-3b9d9b557402	26
749833	Micardis HCT 40 MG /12.5 MG Oral Tablet	PSN	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749837	Micardis-HCT 80 MG / 12.5 MG Oral Tablet	PSN	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749841	Micardis-HCT 80 MG / 25 MG Oral Tablet	PSN	539cdfb4-b920-48fb-8176-fe23841e3d32	2
283316	telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	539cdfb4-b920-48fb-8176-fe23841e3d32	2
283317	telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	539cdfb4-b920-48fb-8176-fe23841e3d32	2
477130	telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749833	hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral Tablet [Micardis-HCT]	SBD	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749837	hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]	SBD	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749841	hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]	SBD	539cdfb4-b920-48fb-8176-fe23841e3d32	2
283316	hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral Tablet	SCD	539cdfb4-b920-48fb-8176-fe23841e3d32	2
283317	hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral Tablet	SCD	539cdfb4-b920-48fb-8176-fe23841e3d32	2
477130	hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet	SCD	539cdfb4-b920-48fb-8176-fe23841e3d32	2
283316	HCTZ 12.5 MG / telmisartan 40 MG Oral Tablet	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749833	HCTZ 12.5 MG / telmisartan 40 MG Oral Tablet [Micardis-HCT]	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2
283317	HCTZ 12.5 MG / telmisartan 80 MG Oral Tablet	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749837	HCTZ 12.5 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2
477130	HCTZ 25 MG / telmisartan 80 MG Oral Tablet	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749841	HCTZ 25 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749833	Micardis-HCT 40/12.5 (telmisartan / hydrochlorothiazide) Oral Tablet	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749833	Micardis-HCT 40/12.5 Oral Tablet	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749837	Micardis-HCT 80/12.5 (telmisartan / hydrochlorothiazide) Oral Tablet	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749837	Micardis-HCT 80/12.5 Oral Tablet	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749841	Micardis-HCT 80/25 (telmisartan / hydrochlorothiazide) Oral Tablet	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2
749841	Micardis-HCT 80/25 Oral Tablet	SY	539cdfb4-b920-48fb-8176-fe23841e3d32	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0597-0044-37	00597004437	3 BLISTER PACK in 1 CARTON (0597-0044-37) / 10 TABLET in 1 BLISTER PACK	3 blister pack	2000-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Micardis HCT	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| Rottendorf Pharma GmbH \| Boehringer Ingelheim Promeco S.A. de C.V. \| Sixarp, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	26
Micardis ® HCT (telmisartan and hydrochlorothiazide) Tablets, 40 mg/12.5 mg 80 mg/12.5 mg and 80 mg/25 mg	Physicians Total Care, Inc.	2012-02-14	HUMAN PRESCRIPTION DRUG LABEL	2