NDC Code(s) : 71335-1777-1, 71335-1777-2, 71335-1777-3, 71335-1777-4, 71335-1777-5, 71335-1777-6, 71335-1777-7, 71335-1777-8, 71335-1777-9, 71335-1777-0
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SildenafilSildenafil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-1777(NDC:0093-5343)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILDENAFIL CITRATE(UNII: BW9B0ZE037)
(SILDENAFIL - UNII:3M7OB98Y7H) 		SILDENAFIL100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (modified oval-shaped) Size 15 mm
Flavor Imprint Code TEVA;5343
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71335-1777-110 in 1 BOTTLE Type 0: Not a Combination Product03/11/2021
2NDC:71335-1777-25 in 1 BOTTLE Type 0: Not a Combination Product03/11/2021
3NDC:71335-1777-330 in 1 BOTTLE Type 0: Not a Combination Product03/11/2021
4NDC:71335-1777-42 in 1 BOTTLE Type 0: Not a Combination Product03/11/2021
5NDC:71335-1777-56 in 1 BOTTLE Type 0: Not a Combination Product03/11/2021
6NDC:71335-1777-620 in 1 BOTTLE Type 0: Not a Combination Product03/11/2021
7NDC:71335-1777-74 in 1 BOTTLE Type 0: Not a Combination Product03/11/2021
8NDC:71335-1777-890 in 1 BOTTLE Type 0: Not a Combination Product03/11/2021
9NDC:71335-1777-960 in 1 BOTTLE Type 0: Not a Combination Product03/11/2021
10NDC:71335-1777-015 in 1 BOTTLE Type 0: Not a Combination Product03/11/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077342 12/11/2017

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-1777), RELABEL(71335-1777)

PRINCIPAL DISPLAY PANEL

Sildenafil Citrate 100mg Tab

Label