Telmisartan and Hydrochlorothiazide

Product NDC: 46708-210
11-digit product format: 467080210
Labeler code: 46708
Product ID: 46708-210_7c37a82a-77c2-4d49-84ee-ee4f70b4ec93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Telmisartan and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA203010
Marketing category: ANDA
Marketing start: 2014-03-14
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	Approval date
A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25
A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25
A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET / ORAL	AB	2014-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203010-001	AB
A203010-002	AB
A203010-003	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-002	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;80MG	TABLET / ORAL	AB	2014-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-003	TELMISARTAN AND HYDROCHLOROTHIAZIDE	25MG;80MG	TABLET / ORAL	AB	2014-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203010-001	TELMISARTAN AND HYDROCHLOROTHIAZIDE	12.5MG;40MG	TABLET / ORAL	AB	2014-02-25	`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	A203010-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203010-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203010-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203010-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203010-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203010-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203010-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203010-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203010-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203010-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203010-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203010-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203010-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203010-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203010-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203010-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203010-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203010-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203010-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203010-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203010-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203010-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203010-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203010-001	AB	1	`301d65b070ca…`

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: Telmisartan and Hydrochlorothiazide
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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283316	Internal RxNorm lookup
283317	Internal RxNorm lookup
477130	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
5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
46708-210-10	2023-02-04	Telmisartan and Hydrochlorothiazide Tablets, USP Rx only Prescribing Information
46708-210-30	2023-02-04	Telmisartan and Hydrochlorothiazide Tablets, USP Rx only Prescribing Information
46708-210-91	2023-02-04	Telmisartan and Hydrochlorothiazide Tablets, USP Rx only Prescribing Information
46708-210-10	2023-01-30	Telmisartan and Hydrochlorothiazide Tablets, USP Rx only Prescribing Information
46708-210-30	2023-01-30	Telmisartan and Hydrochlorothiazide Tablets, USP Rx only Prescribing Information
46708-210-91	2023-01-30	Telmisartan and Hydrochlorothiazide Tablets, USP Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46708-210-10	Telmisartan and Hydrochlorothiazide	100 in 1 CARTON	TABLET	100	3
46708-210-30	Telmisartan and Hydrochlorothiazide	30 in 1 BOTTLE	TABLET	30	3
46708-210-91	Telmisartan and Hydrochlorothiazide	1000 in 1 BOTTLE	TABLET	1000	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
TELMISARTAN	ACTIVE INGREDIENT	U5SYW473RQ	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
TELMISARTAN	ACTIVE MOIETY	U5SYW473RQ	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET TELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-210	TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]	3	Current NDC, Legacy NDC, 3 package rows	20230204_5b476740-e3f0-4f68-b07c-cd9eb2fa27ca.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Inc.	e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7	2023-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203010 application number: ANDA203010
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Limited	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	2023-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203010 application number: ANDA203010 ndc (product): 46708-210

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
283316	telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	3
283317	telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	3
477130	telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	3
283316	hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral Tablet	SCD	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	3
283317	hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral Tablet	SCD	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	3
477130	hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet	SCD	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	3
283316	HCTZ 12.5 MG / telmisartan 40 MG Oral Tablet	SY	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	3
283317	HCTZ 12.5 MG / telmisartan 80 MG Oral Tablet	SY	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	3
477130	HCTZ 25 MG / telmisartan 80 MG Oral Tablet	SY	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-210-10	46708021010	100 TABLET in 1 CARTON (46708-210-10)	100 tablet	2014-03-14	0000-00-00	No	No	Current
46708-210-30	46708021030	30 TABLET in 1 BOTTLE (46708-210-30)	30 tablet	2014-03-14	0000-00-00	No	No	Current
46708-210-91	46708021091	1000 TABLET in 1 BOTTLE (46708-210-91)	1000 tablet	2014-03-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Telmisartan and Hydrochlorothiazide Tablets, USP Rx only Prescribing Information	Alembic Pharmaceuticals Limited	2023-01-23	Human Prescription Drug Label	3