Telmisartan
These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral useInitial U.S. Approval: 1998
Approved
Approval ID
eaed12cd-5bfe-4c98-9afc-025ed86a294f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 6, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
telmisartan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-5490
Application NumberANDA202397
Product Classification
M
Marketing Category
C73584
G
Generic Name
telmisartan
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2018
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TELMISARTANActive
Quantity: 40 mg in 1 1
Code: U5SYW473RQ
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT