NDC 68071-3892-01 - Telmisartan

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68071-3892
Requested NDC: 68071-3892-01
Package NDCs from labels: 68071-3892-1, 68071-3892-01
Manufacturer: NuCare Pharmaceuticals, Inc.
Effective date: 2025-09-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Telmisartan - NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc.	2025-09-17	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3892-1	Telmisartan	100 in 1 BOTTLE	TABLET	100		1

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 3 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Telmisartan	TELMISARTAN	Bryant Ranch Prepack	f13e0919-5ee2-4855-b7c8-c8ab423769dd	2024-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205305 unii: U5SYW473RQ
Telmisartan	TELMISARTAN	Lifestar Pharma LLC	3ff464e6-7a36-4544-a06f-7848414f77fc	2024-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205304 rxcui: 282755 rxcui: 205305 unii: U5SYW473RQ
telmisartan	TELMISARTAN	Zydus Lifesciences Limited	2e3cc412-fa44-4304-aabc-d6e412f81fbf	2024-08-12		Exact identifier rxcui: 205304 rxcui: 282755 rxcui: 205305 unii: U5SYW473RQ
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	681dfb5c-fc5c-427e-81f6-4b4e934978a2	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U5SYW473RQ
Telmisartan	TELMISARTAN	NuCare Pharmaceuticals,Inc.	a020e2a7-d1e7-8ae0-e053-2995a90abad3	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205305 unii: U5SYW473RQ
Telmisartan	TELMISARTAN	Aurobindo Pharma Limited	fef6532d-438a-435e-a61f-216dd8551339	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205304 rxcui: 282755 rxcui: 205305 unii: U5SYW473RQ
MANNITOL	MANNITOL	HF Acquisition Co LLC, DBA HealthFirst	999ce711-2d5b-0d7d-e053-2995a90a2689	2024-01-27	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Telmisartan and Amlodipine	TELMISARTAN AND AMLODIPINE	Lupin Pharmaceuticals, Inc.	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	2023-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U5SYW473RQ
telmisartan	TELMISARTAN	Zydus Pharmaceuticals USA Inc.	e61c209a-4fc3-4f5c-b526-6412f0b8897c	2023-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205304 rxcui: 282755 rxcui: 205305 unii: U5SYW473RQ
Telmisartan	TELMISARTAN	Amneal Pharmaceuticals LLC	20a60231-64f0-4751-aa81-6c0e64334179	2023-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205304 rxcui: 282755 rxcui: 205305 unii: U5SYW473RQ
Telmisartan	TELMISARTAN	Modavar Pharmaceuticals LLC	a075633a-2a2a-4e88-8ede-b49a3920a16c	2023-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205304 rxcui: 282755 rxcui: 205305 unii: U5SYW473RQ
Telmisartan	TELMISARTAN	A-S Medication Solutions	509cd338-24db-41d1-a115-9dc999170717	2023-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205305 unii: U5SYW473RQ
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Inc.	e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7	2023-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U5SYW473RQ
Mannitol	MANNITOL	B. Braun Medical Inc.	d12cc802-b538-4065-a264-f474ff3b3043	2023-08-15	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Telmisartan	TELMISARTAN	Cadila Pharmaceuticals Limited	353fcb30-2fa7-4ff1-8a18-26f3ec279d00	2023-08-02	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205304 rxcui: 282755 rxcui: 205305 unii: U5SYW473RQ
Telmisartan	TELMISARTAN	Amneal Pharmaceuticals of New York LLC	bf2dca37-ce9c-40e4-8ad6-b8186aa7fed1	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205304 rxcui: 282755 rxcui: 205305 unii: U5SYW473RQ
Mannitol	MANNITOL	Fresenius Kabi USA, LLC	c395e13d-6ea1-4104-8b37-669cfb982f04	2023-03-16	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Telmisartan	TELMISARTAN	Mylan Pharmaceuticals Inc.	c3658bc8-1524-43db-930e-66f9ac01b808	2023-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 205304 rxcui: 282755 rxcui: 205305 unii: U5SYW473RQ
Telmisartan and Amlodipine	TELMISARTAN AND AMLODIPINE	Alembic Pharmaceuticals Limited	15b438b4-4874-43f4-a50a-4e6f3e5530ac	2023-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U5SYW473RQ
Telmisartan and Hydrochlorothiazide	TELMISARTAN AND HYDROCHLOROTHIAZIDE	Alembic Pharmaceuticals Limited	5b476740-e3f0-4f68-b07c-cd9eb2fa27ca	2023-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U5SYW473RQ

Reported adverse events (FAERS/openFDA)#

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