NDC Code(s) : 13107-058-30, 13107-058-01, 13107-058-05, 13107-058-99, 13107-059-30, 13107-059-01, 13107-059-05, 13107-059-99, 13107-060-30, 13107-060-01, 13107-060-05, 13107-060-99
Packager : Aurolife Pharma, LLC

Category : Human Prescription Drug Label

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:13107-058
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN300 mg
CODEINE PHOSPHATE(UNII: GSL05Y1MN6)
(CODEINE ANHYDROUS - UNII:UX6OWY2V7J) 		CODEINE PHOSPHATE15 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE (White to Off White) Score no score
Shape ROUND (Flat-faced, Beveled Edge) Size 11 mm
Flavor Imprint Code U35
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13107-058-3030 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
2NDC:13107-058-01100 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
3NDC:13107-058-05500 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
4NDC:13107-058-991000 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202800 04/15/2013
Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:13107-059
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN300 mg
CODEINE PHOSPHATE(UNII: GSL05Y1MN6)
(CODEINE ANHYDROUS - UNII:UX6OWY2V7J) 		CODEINE PHOSPHATE30 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE (White to Off White) Score no score
Shape ROUND (Flat-faced, Beveled Edge) Size 11 mm
Flavor Imprint Code U36
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13107-059-3030 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
2NDC:13107-059-01100 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
3NDC:13107-059-05500 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
4NDC:13107-059-991000 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202800 04/15/2013
Acetaminophen and Codeine PhosphateAcetaminophen and Codeine Phosphate TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:13107-060
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN300 mg
CODEINE PHOSPHATE(UNII: GSL05Y1MN6)
(CODEINE ANHYDROUS - UNII:UX6OWY2V7J) 		CODEINE PHOSPHATE60 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE (White to Off White) Score no score
Shape ROUND (Flat-faced, Beveled Edge) Size 11 mm
Flavor Imprint Code U37
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13107-060-3030 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
2NDC:13107-060-01100 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
3NDC:13107-060-05500 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
4NDC:13107-060-991000 in 1 BOTTLE Type 0: Not a Combination Product15/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202800 04/15/2013

LABELER - Aurolife Pharma, LLC(829084461)

Establishment
Name Address ID/FEI Business Operations
Aurolife Pharma, LLC 829084461 MANUFACTURE(13107-058, 13107-059, 13107-060)

PRINCIPAL DISPLAY PANEL

NDC 13107-058-01
Acetaminophen and Codeine Phosphate Tablets, USP
300 mg/15 mg CIII
Rx only             100 Tablets
AUROBINDO


300-15mg

300-15mg

PRINCIPAL DISPLAY PANEL

NDC 13107-059-01
Acetaminophen and Codeine Phosphate Tablets, USP
300 mg/30 mg CIII
Rx only             100 Tablets
AUROBINDO

300-30mg

300-30mg

PRINCIPAL DISPLAY PANEL

NDC 13107-060-01
Acetaminophen and Codeine Phosphate Tablets, USP
300 mg/60 mg CIII
Rx only             100 Tablets
AUROBINDO

300-60mg

300-60mg