Tamsulosin Hydrochloride
These highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
9108b999-4b99-469d-99a8-5ef0fa4ca00a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2025
Manufacturers
FDA
XLCare Pharmaceuticals, Inc
DUNS: 080991142
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tamsulosin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-282
Application NumberANDA214730
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tamsulosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2025
FDA Product Classification
INGREDIENTS (16)
TAMSULOSIN HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 1
Code: 11SV1951MR
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT