NDC Code(s) : 43386-920-60
Packager : Lupin Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Oxycodone HydrochlorideOxycodone Hydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43386-920
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE(UNII: C1ENJ2TE6C)
(OXYCODONE - UNII:CD35PMG570) 		OXYCODONE HYDROCHLORIDE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
WATER(UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SORBITOL(UNII: 506T60A25R)
BERRY(UNII: FV3431923Z)
Product Characteristics
Color YELLOW Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43386-920-601 in 1 CARTON 29/04/2015
130 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204603 04/29/2015

LABELER - Lupin Pharmaceuticals, Inc.(089153071)

REGISTRANT - Novel Laboratories, Inc.(793518643)

Establishment
Name Address ID/FEI Business Operations
Novel Laboratories, Inc. 793518643 ANALYSIS(43386-920), MANUFACTURE(43386-920), PACK(43386-920)

PRINCIPAL DISPLAY PANEL

Container Label:

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Carton Label:

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