LEVONORGESTREL AND ETHINYL ESTRADIOL - levonorgestrel and ethinyl estradiol 
Jai Pharma Limited

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Levonorgestrel and Ethinyl Estradiol Tablets USP, (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets USP, (0.01 mg)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
LEVONORGESTREL AND ETHINYL ESTRADIOL  
levonorgestrel and ethinyl estradiol kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57994-008
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57994-008-902 in 1 CARTON01/01/2017
11 in 1 POUCH
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1 84 
Part 2 7 
Part 1 of 2
LEVONORGESTREL AND ETHINYL ESTRADIOL  
levonorgestrel and ethinyl estradiol tablet
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL0.1 mg
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL0.02 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 214
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20049301/01/2017
Part 2 of 2
ETHINYL ESTRADIOL  
ethinyl estradiol tablet
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL0.01 mg
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
POVIDONE K25 (UNII: K0KQV10C35)  
Product Characteristics
ColorORANGE (Light Peach) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code 215
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20049301/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20049301/01/2017
Labeler - Jai Pharma Limited (650882132)
Registrant - Jai Pharma Limited (650882132)
Establishment
NameAddressID/FEIBusiness Operations
Jai Pharma Limited677604150analysis(57994-008) , label(57994-008) , manufacture(57994-008) , pack(57994-008)

Revised: 9/2016
Document Id: b175b0fd-79f5-4001-b371-30e859522c5b
Set id: 4dfb7ef1-c14a-4175-9409-a30232844c33
Version: 1
Effective Time: 20160927
 
Jai Pharma Limited