NDC Code(s) : 52544-071-01, 52544-162-01, 52544-162-05, 52544-161-01, 52544-161-05
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NorcoHydrocodone Bitatrate and Acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52544-071
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE(UNII: NO70W886KK)
(HYDROCODONE - UNII:6YKS4Y3WQ7) 		HYDROCODONE BITARTRATE5 mg
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule-shaped) Size 14 mm
Flavor Imprint Code NORCO;071
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52544-071-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040148 05/01/2016 03/31/2019
NorcoHydrocodone Bitatrate and Acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52544-162
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE(UNII: NO70W886KK)
(HYDROCODONE - UNII:6YKS4Y3WQ7) 		HYDROCODONE BITARTRATE7.5 mg
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule-shaped) Size 14 mm
Flavor Imprint Code NORCO;729
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52544-162-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/12/2013
2NDC:52544-162-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/12/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040148 03/12/2013 03/31/2019
NorcoHydrocodone Bitatrate and Acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52544-161
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE(UNII: NO70W886KK)
(HYDROCODONE - UNII:6YKS4Y3WQ7) 		HYDROCODONE BITARTRATE10 mg
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule-shaped) Size 14 mm
Flavor Imprint Code NORCO;539
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52544-161-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/12/2013
2NDC:52544-161-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/12/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040148 03/12/2013 03/31/2019

PRINCIPAL DISPLAY PANEL

NDC 52544-071-01
NORCO 5/325
5 mg/325 mg
100 Tablets
Rx Only

PRINCIPAL DISPLAY PANEL NDC 52544-071-01 NORCO 5/325 5 mg/325 mg 100 Tablets Rx Only

PRINCIPAL DISPLAY PANEL

NDC 52544-062-01
NORCO 7.5/325
7.5 mg/325 mg
100 Tablets
Rx Only

PRINCIPAL DISPLAY PANEL NDC 52544-062-01 NORCO 7.5/325 7.5 mg/325 mg 100 Tablets Rx Only

PRINCIPAL DISPLAY PANEL

NDC 52544-061-01
NORCO 10/325
10 mg/325 mg
100 Tablets
Rx Only

PRINCIPAL DISPLAY PANEL NDC 52544-061-01 NORCO 10/325 10 mg/325 mg 100 Tablets Rx Only