Tadalafil (Page 13 of 13)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC: 70934-795-15

Label
(click image for full-size original)
TADALAFIL tadalafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70934-795(NDC:16729-372)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TADALAFIL (TADALAFIL) TADALAFIL 20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
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 Score no score
Shape OVAL (almond) Size 12mm
Flavor Imprint Code FJ4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70934-795-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:70934-795-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209167 10/16/2020 11/30/2023
Labeler — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Registrant — Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546)
Establishment
Name Address ID/FEI Operations
Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack (70934-795)

Revised: 01/2023 Denton Pharma, Inc. DBA Northwind Pharmaceuticals

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