TAMSULOSIN HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE
Approved
Approval ID
255eab95-a7aa-3a37-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2020
Manufacturers
FDA
DirectRX
DUNS: 079254320
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 Code61919-298
Application NumberANDA202433
Product Classification
M
Marketing Category
C73584
G
Generic Name
TAMSULOSIN HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2020
FDA Product Classification
INGREDIENTS (20)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TAMSULOSIN HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 1
Code: 11SV1951MR
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT