Levora (Page 8 of 8)

Repackaged by: REBEL DISTRIBUTORS CORP. Thousand Oaks, CA 91320

Image 4

PRINCIPAL DISPLAY PANEL

Levora 0.15mg/0.03mg
(click image for full-size original)
LEVORA levonorgestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-260(NDC:52544-279)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-260-28 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (42254-260-28)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
LEVORA levonorgestrel and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 0.15 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONES
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 1530;WATSON
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073594
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color ORANGE (Peach) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code WATSON;P1
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073594
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073594 04/10/2002
Labeler — Rebel Distributors Corp (118802834)
Registrant — PSS World Medical, Inc. (101822862)
Establishment
Name Address ID/FEI Operations
PSS World Medical, Inc. 791528623 REPACK (42254-260)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 REPACK (42254-260)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 RELABEL (42254-260), REPACK (42254-260)
Establishment
Name Address ID/FEI Operations
SCRIPT PAK 964420108 RELABEL (42254-260), REPACK (42254-260)
Establishment
Name Address ID/FEI Operations
Keltman Pharmaceuticals, Inc. 362861077 REPACK (42254-260)
Establishment
Name Address ID/FEI Operations
Rebel Distirbutors Corp. 118802834 RELABEL (42254-260), REPACK (42254-260)

Revised: 07/2012 Rebel Distributors Corp

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