NDC Code(s) : 55154-7269-9, 55154-7269-7, 55154-7270-9, 55154-7270-8, 55154-7270-7, 55154-7271-9, 55154-7271-7, 55154-7272-9, 55154-7272-8, 55154-7272-7, 55154-7273-9, 55154-7273-8, 55154-7273-7, 55154-7274-9, 55154-7274-8, 55154-7274-7
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7269(NDC:0406-0365)
Route of Administration ORAL DEA Schedule CIII
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
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 15 mm
Flavor Imprint Code M365
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-7269-930 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:55154-7269-714 in 1 BLISTER PACK Type 0: Not a Combination Product22/04/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040409 04/22/2010
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7270(NDC:0406-0357)
Route of Administration ORAL DEA Schedule CIII
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) 		ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 17 mm
Flavor Imprint Code M357
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-7270-930 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:55154-7270-82000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:55154-7270-714 in 1 BLISTER PACK Type 0: Not a Combination Product22/04/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089160 04/22/2010 07/31/2016
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7271(NDC:0406-0366)
Route of Administration ORAL DEA Schedule CIII
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
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code M366
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-7271-930 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:55154-7271-714 in 1 BLISTER PACK Type 0: Not a Combination Product22/04/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040405 04/22/2010
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7272(NDC:0406-0358)
Route of Administration ORAL DEA Schedule CIII
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) 		ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 17 mm
Flavor Imprint Code M358
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-7272-930 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:55154-7272-82000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:55154-7272-714 in 1 BLISTER PACK Type 0: Not a Combination Product22/04/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040201 04/22/2010 07/31/2017
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7273(NDC:0406-0367)
Route of Administration ORAL DEA Schedule CIII
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
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 15 mm
Flavor Imprint Code M367
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-7273-930 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:55154-7273-81500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:55154-7273-714 in 1 BLISTER PACK Type 0: Not a Combination Product22/04/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040400 04/22/2010
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7274(NDC:0406-0363)
Route of Administration ORAL DEA Schedule CIII
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) 		ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 17 mm
Flavor Imprint Code M363
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-7274-930 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:55154-7274-81500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:55154-7274-714 in 1 BLISTER PACK Type 0: Not a Combination Product22/04/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040201 04/22/2010 08/31/2015

PRINCIPAL DISPLAY PANEL

Hydrocodone Bitartrate and Acetaminophen tablets USP CIII

5 mg/325 mg

QTY 30 Tablets

Label

PRINCIPAL DISPLAY PANEL

Hydrocodone Bitartrate and Acetaminophen tablets USP CIII

5 mg/500 mg

QTY 30 Tablets

Label

PRINCIPAL DISPLAY PANEL

Hydrocodone Bitartrate and Acetaminophen tablets USP CIII

7.5 mg/325 mg

QTY 30 Tablets

Label

PRINCIPAL DISPLAY PANEL

Hydrocodone Bitartrate and Acetaminophen tablets USP CIII

7.5 mg/500 mg

QTY 30 Tablets

Label

PRINCIPAL DISPLAY PANEL

Hydrocodone Bitartrate and Acetaminophen tablets USP CIII

10 mg/325 mg

Card Label

PRINCIPAL DISPLAY PANEL

Hydrocodone Bitartrate and Acetaminophen tablets USP CIII

10 mg/325 mg

QTY 30 Tablets

Lidding Label

PRINCIPAL DISPLAY PANEL

Hydrocodone Bitartrate and Acetaminophen tablets USP CIII

10 mg/500 mg

QTY 30 Tablets

Label

PRINCIPAL DISPLAY PANEL

Hydrocodone Bitartrate and Acetaminophen tablets USP CIII

5 mg/500 mg

Approximately 2000 Tablets

Label

PRINCIPAL DISPLAY PANEL

Hydrocodone Bitartrate and Acetaminophen tablets USP CIII

7.5 mg/500 mg

Approximately 2000 Tablets

Label

PRINCIPAL DISPLAY PANEL

Hydrocodone Bitartrate and Acetaminophen tablets USP CIII

10 mg/325 mg

Approximately 1500 Tablets

Label

PRINCIPAL DISPLAY PANEL

Hydrocodone Bitartrate and Acetaminophen tablets USP CIII

10 mg/500 mg

Approximately 1500 Tablets

Label