Tamsulosin hydrochloride
Tamsulosin hydrochloride capsules USP, for oral use Initial U.S. Approval: 1997 These highlights do not include all the information needed to use tamsulosin hydrochloride capsules USP safely and effectively. See full prescribing information for tamsulosin hydrochloride capsules USP.
Approved
Approval ID
d6e4cf51-e8cb-08c4-e053-2a95a90aefd7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 4, 2022
Manufacturers
FDA
QYK BRANDS LLC
DUNS: 081560441
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 Code73750-099
Application NumberANDA211885
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tamsulosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2022
FDA Product Classification
INGREDIENTS (9)
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TAMSULOSIN HYDROCHLORIDEActive
Quantity: 0.4 mg in 0.4 mg
Code: 11SV1951MR
Classification: ACTIB
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT