Prescription Drug Information: Tadalafil (Page 11 of 11)

TADALAFIL TABLET, FILM COATED

Label Image
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TADALAFIL tadalafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-0370(NDC:16729-370)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL (TADALAFIL) TADALAFIL 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
SORBITAN MONOSTEARATE
MAGNESIUM STEARATE
FERRIC OXIDE YELLOW
TALC
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color yellow (light yellow) Score no score
Shape OVAL (almond) Size 10mm
Flavor Imprint Code FJ2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50436-0370-2 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50436-0370-1 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209167 03/27/2019
Labeler — Unit Dose Services (831995316)
Establishment
Name Address ID/FEI Operations
Unit Dose Services 831995316 REPACK (50436-0370), RELABEL (50436-0370)

Revised: 09/2022 Unit Dose Services

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