Tamsulosin Hydrochloride (Page 6 of 6)

PRINCIPAL DISPLAY PANEL-Label


NDC 63187-469-30
Tamsulosin Hydrochloride Capsules, USP
0.4 mg
Rx only
30 CAPSULES.
PHARMACIST: PLEASE DISPENSE WITH PATIENT INFORMATION LEAFLET

63187-469-30
(click image for full-size original)
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-469(NDC:62756-160)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN) TAMSULOSIN HYDROCHLORIDE 0.4 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)
TRIETHYL CITRATE
TALC
SODIUM LAURYL SULFATE
GELATIN, UNSPECIFIED
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (olive green) , YELLOW (light yellow) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 160
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-469-30 30 CAPSULE in 1 BOTTLE None
2 NDC:63187-469-60 60 CAPSULE in 1 BOTTLE None
3 NDC:63187-469-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090931 07/15/2010
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-469), RELABEL (63187-469)

Revised: 01/2021 Proficient Rx LP

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