NDC 65841-804-30 - 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: 65841-804
Requested NDC: 65841-804-30
Package NDCs from labels: 65841-804-06, 65841-804-16, 65841-804-01, 65841-804-05, 65841-804-10, 65841-804-30, 65841-804-78
Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-08-12
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
telmisartan - Zydus Lifesciences Limited	Zydus Lifesciences Limited	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65841-804-01	telmisartan	100 in 1 BOTTLE	TABLET	100	8
65841-804-05	telmisartan	500 in 1 BOTTLE	TABLET	500	8
65841-804-06	telmisartan	30 in 1 BOTTLE	TABLET	30	8
65841-804-10	telmisartan	1000 in 1 BOTTLE	TABLET	1000	8
65841-804-16	telmisartan	90 in 1 BOTTLE	TABLET	90	8
65841-804-30	telmisartan	1 in 1 BLISTER PACK	TABLET	1	8
65841-804-78	telmisartan	30 in 1 CARTON	TABLET	30	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-804	TELMISARTAN TABLET [ZYDUS LIFESCIENCES LIMITED]	8	Current NDC, Legacy NDC, 7 package rows	20240815_2e3cc412-fa44-4304-aabc-d6e412f81fbf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TELMISARTAN	ACTIVE INGREDIENT	U5SYW473RQ	TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]	1
TELMISARTAN	ACTIVE MOIETY	U5SYW473RQ	TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]	1
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]	1
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TELMISARTAN TABLET [CADILA HEALTHCARE LIMITED]	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 9 of 10 · 185 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Kroger Company	f7ad77fc-d890-25b9-e053-6394a90a2b12	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
Equaline Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	United Natural Foods, Inc.	f7602789-179a-edfc-e053-6294a90a0844	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
Topcare Health Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Topco Associates LLC	9c614c0e-5862-682f-e053-2a95a90abc09	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
TopCare Health Advanced Moisturizing Plus Redness Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Topco Associates LLC	9c6193a6-d822-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
HEB Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	HEB Grocery Company, LP	f76281d6-3aea-349b-e053-6394a90afca2	2023-12-20	Warnings	Exact identifier unii: FZ989GH94E
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
Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Proficient Rx LP	73e12596-6dd5-4cd2-83ed-992e1211b4b8	2023-12-01	Warnings	Exact identifier unii: FZ989GH94E
telmisartan	TELMISARTAN	Zydus Pharmaceuticals USA Inc.	e61c209a-4fc3-4f5c-b526-6412f0b8897c	2023-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA203325 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
Lipotox	SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,	BioActive Nutritional, Inc.	a1538692-ca00-4e52-9b7e-409767ee27e1	2023-09-05	Warnings	Exact identifier unii: 506T60A25R
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier unii: 506T60A25R
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
Ferrum Oxydatum	FERRUM OXYDATUM	Hahnemann Laboratories, INC.	f8b52d3f-3fe2-a850-e053-6394a90a5d9f	2023-04-06		Exact identifier unii: 1K09F3G675
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.