HEATHER (Page 5 of 5)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

carton
(click image for full-size original)

Carton

Carton

pouch
(click image for full-size original)

Pouch

Pouch

HEATHER
norethindrone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-303
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORETHINDRONE (NORETHINDRONE) NORETHINDRONE 0.35 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
TALC
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code G;303
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-303-29 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 28 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68462-303-29)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090454 04/23/2010
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS (68462-303), MANUFACTURE (68462-303)

Revised: 08/2021 Glenmark Pharmaceuticals Inc., USA

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