NDC Code(s) : 43598-635-52, 43598-635-10, 43598-636-52, 43598-636-10, 43598-637-52, 43598-637-10
Packager : Dr.Reddy's Laboratories Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LevetiracetamLevetiracetam Injection INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-635
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levetiracetam(UNII: 44YRR34555)
(Levetiracetam - UNII:44YRR34555) 		Levetiracetam5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride(UNII: 451W47IQ8X)
Acetic Acid(UNII: Q40Q9N063P)
Sodium Acetate(UNII: 4550K0SC9B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-635-1010 in 1 CARTON 06/08/2018
1NDC:43598-635-52100 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206880 06/08/2018
LevetiracetamLevetiracetam Injection INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-636
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levetiracetam(UNII: 44YRR34555)
(Levetiracetam - UNII:44YRR34555) 		Levetiracetam10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride(UNII: 451W47IQ8X)
Acetic Acid(UNII: Q40Q9N063P)
Sodium Acetate(UNII: 4550K0SC9B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-636-1010 in 1 CARTON 06/08/2018
1NDC:43598-636-52100 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206880 06/08/2018
LevetiracetamLevetiracetam Injection INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-637
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levetiracetam(UNII: 44YRR34555)
(Levetiracetam - UNII:44YRR34555) 		Levetiracetam15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride(UNII: 451W47IQ8X)
Acetic Acid(UNII: Q40Q9N063P)
Sodium Acetate(UNII: 4550K0SC9B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-637-1010 in 1 CARTON 06/08/2018
1NDC:43598-637-52100 mL in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206880 06/08/2018

LABELER - Dr.Reddy's Laboratories Inc(802315887)

REGISTRANT - GLAND PHARMA LIMITED(918601238)

Establishment
Name Address ID/FEI Business Operations
GLAND PHARMA LIMITED 918601238 analysis(43598-635, 43598-636, 43598-637), manufacture(43598-635, 43598-636, 43598-637)

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Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number

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