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. Initial U.S. Approval: 1997
Approved
Approval ID
7350ad6e-7745-4743-9aa4-2a14ff01fef4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 2010
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
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 Code67046-720
Application NumberANDA078225
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tamsulosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2010
FDA Product Classification
INGREDIENTS (14)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TAMSULOSIN HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 1
Code: 11SV1951MR
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT