Jencycla (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jencycla™

(norethindrone tablets USP)

0.35 mg

Carton Pack:

NDC: 68180-877-13

3 Wallets of 28 Tablets Each

Jencycla
(norethindrone tablets USP)
0.35 mg
28 Day Regimen
Carton Pack:
NDC: 68180-877-13
3 Wallets of 28 Tablets Each
(click image for full-size original)

Jencycla™

(norethindrone tablets USP)

0.35 mg

Wallet Pack:

NDC: 68180-877-11

1 Wallet of 28 Tablets

Jencycla
(norethindrone tablets USP)
0.35 mg
28 Day Regimen
Wallet Pack:
NDC: 68180-877-11
1 Wallet of 28 Tablets
(click image for full-size original)
JENCYCLA norethindrone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-877
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
ANHYDROUS LACTOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
MAGNESIUM STEARATE
Product Characteristics
Color GREEN (green) Score no score
Shape ROUND (round) Size 6mm
Flavor Imprint Code LU;O23
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-877-13 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (57297-877-11)
1 NDC:57297-877-11 28 TABLET in 1 BLISTER PACK This package is contained within the CARTON (57297-877-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091323 05/08/2013
Labeler — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650582310 manufacture (57297-877), pack (57297-877)

Revised: 02/2016 LUPIN LIMITED

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