NDC Code(s) : 50474-930-01, 50474-930-50, 50474-931-01, 50474-931-50, 50474-932-01, 50474-932-50
Packager : UCB, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lortab 5/325 hydrocodone bitartrate and acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-930
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)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Stearic acid(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 16 mm
Flavor Imprint Code G;035
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50474-930-01100 in 1 BOTTLE Type 0: Not a Combination Product21/04/2014
2NDC:50474-930-50500 in 1 BOTTLE Type 0: Not a Combination Product21/04/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202214 04/21/2014 06/30/2017
Lortab 7.5/325 hydrocodone bitartrate and acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-931
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)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Stearic acid(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 16 mm
Flavor Imprint Code G;036
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50474-931-01100 in 1 BOTTLE Type 0: Not a Combination Product21/04/2014
2NDC:50474-931-50500 in 1 BOTTLE Type 0: Not a Combination Product21/04/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202214 04/21/2014 06/30/2017
Lortab 10/325 hydrocodone bitartrate and acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-932
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)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Stearic acid(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 16 mm
Flavor Imprint Code G;037
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50474-932-01100 in 1 BOTTLE Type 0: Not a Combination Product21/04/2014
2NDC:50474-932-50500 in 1 BOTTLE Type 0: Not a Combination Product21/04/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202214 04/21/2014 06/30/2017

PRINCIPAL DISPLAY PANEL

ucb

NDC 50474-930-01
100 TABLETS

LORTAB® 5/325

HYDROCODONE BITARTRATE
AND ACETAMINOPHEN
TABLETS, USP
5 mg/325 mg
CII

MULTIPLE STRENGTHS: DO NOT DISPENSE
UNLESS STRENGTH IS STATED.

Each tablet contains:

Hydrocodone Bitartrate
5 mg
Acetaminophen
325 mg

Rx only

PRINCIPAL DISPLAY PANEL - 5 mg/325 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

ucb

NDC 50474-931-01
100 TABLETS

LORTAB® 7.5/325

HYDROCODONE BITARTRATE
AND ACETAMINOPHEN
TABLETS, USP
7.5 mg/325 mg
CII

MULTIPLE STRENGTHS: DO NOT DISPENSE
UNLESS STRENGTH IS STATED.

Each tablet contains:

Hydrocodone Bitartrate
7.5 mg
Acetaminophen
325 mg

Rx only

PRINCIPAL DISPLAY PANEL - 7.5 mg/325 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

ucb

NDC 50474-932-01
100 TABLETS

LORTAB® 10/325

HYDROCODONE BITARTRATE
AND ACETAMINOPHEN
TABLETS, USP
10 mg/325 mg
CII

MULTIPLE STRENGTHS: DO NOT DISPENSE
UNLESS STRENGTH IS STATED.

Each tablet contains:

Hydrocodone Bitartrate
10 mg
Acetaminophen
325 mg

Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/325 mg Tablet Bottle Label