NDC Code(s) : 42254-243-30
Packager : Rebel Distributors Corp

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LetrozoleLetrozole TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-243(NDC:0093-7620)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LETROZOLE(UNII: 7LKK855W8I)
(LETROZOLE - UNII:7LKK855W8I) 		LETROZOLE2.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL(UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW (dark-yellow) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code TEVA;B1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42254-243-3030 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090289 06/03/2011

LABELER - Rebel Distributors Corp(118802834)

REGISTRANT - PSS World Medical, Inc.(101822862)

Establishment
Name Address ID/FEI Business Operations
PSS World Medical, Inc. 791528623 REPACK(42254-243)

Establishment
Name Address ID/FEI Business Operations
STAT RX USA LLC 786036330 REPACK(42254-243)

Establishment
Name Address ID/FEI Business Operations
Dispensing Solutions, Inc. 066070785 RELABEL(42254-243), REPACK(42254-243)

Establishment
Name Address ID/FEI Business Operations
SCRIPT PAK 964420108 RELABEL(42254-243), REPACK(42254-243)

Establishment
Name Address ID/FEI Business Operations
Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-243)

Establishment
Name Address ID/FEI Business Operations
Rebel Distirbutors Corp. 118802834 RELABEL(42254-243), REPACK(42254-243)

PRINCIPAL DISPLAY PANEL

Letrozole 2.5mg