NDC Code(s) : 35356-654-10, 35356-654-15, 35356-654-20, 35356-654-30, 35356-654-40, 35356-654-60, 35356-654-90, 35356-654-01, 35356-654-00, 35356-654-50
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

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:35356-654(NDC:0591-0349)
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) 		ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE(UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN(UNII: O8232NY3SJ)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule-shaped) Size 18 mm
Flavor Imprint Code WATSON;349
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-654-1010 in 1 BOTTLE, PLASTIC Type 1: Convenience Kit of Co-Package03/04/2012
2NDC:35356-654-1515 in 1 BOTTLE, PLASTIC Type 1: Convenience Kit of Co-Package03/04/2012
3NDC:35356-654-2020 in 1 BOTTLE, PLASTIC Type 1: Convenience Kit of Co-Package03/04/2012
4NDC:35356-654-3030 in 1 BOTTLE, PLASTIC Type 1: Convenience Kit of Co-Package03/04/2012
5NDC:35356-654-4040 in 1 BOTTLE, PLASTIC Type 1: Convenience Kit of Co-Package03/04/2012
6NDC:35356-654-6060 in 1 BOTTLE, PLASTIC Type 1: Convenience Kit of Co-Package03/04/2012
7NDC:35356-654-9090 in 1 BOTTLE, PLASTIC Type 1: Convenience Kit of Co-Package03/04/2012
8NDC:35356-654-01120 in 1 BOTTLE, PLASTIC Type 1: Convenience Kit of Co-Package03/04/2012
9NDC:35356-654-00100 in 1 BOTTLE, PLASTIC Type 1: Convenience Kit of Co-Package03/04/2012
10NDC:35356-654-5050 in 1 BOTTLE, PLASTIC Type 1: Convenience Kit of Co-Package03/04/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089883 04/03/2012 11/11/2013

PRINCIPAL DISPLAY PANEL

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