NDC Code(s) : 71335-0423-1, 71335-0423-2, 71335-0423-3
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IRBESARTANIRBESARTAN TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0423(NDC:62332-042)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRBESARTAN(UNII: J0E2756Z7N)
(IRBESARTAN - UNII:J0E2756Z7N) 		IRBESARTAN150 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
POVIDONE K30(UNII: U725QWY32X)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (White to Off White) Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code L132;150
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71335-0423-130 in 1 BOTTLE Type 0: Not a Combination Product14/02/2019
2NDC:71335-0423-260 in 1 BOTTLE Type 0: Not a Combination Product27/12/2021
3NDC:71335-0423-390 in 1 BOTTLE Type 0: Not a Combination Product27/12/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091236 07/01/2016

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-0423), RELABEL(71335-0423)

PRINCIPAL DISPLAY PANEL

Irbesartan 150mg Tablet

Label