Flomax
These highlights do not include all the information needed to use Flomax safely and effectively. See full prescribing information for Flomax. Flomax (tamsulosin hydrochloride) Capsules, 0.4 mgInitial U.S. Approval: 1997
Approved
Approval ID
c8beeebe-a666-4521-ba3b-a42f2e8a8851
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4356
Application NumberNDA020579
Product Classification
M
Marketing Category
C73594
G
Generic Name
tamsulosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2010
FDA Product Classification
INGREDIENTS (10)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TAMSULOSIN HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 1
Code: 11SV1951MR
Classification: ACTIB
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT