NDC Code(s) : 31722-917-01, 31722-917-05, 31722-918-01, 31722-918-05
Packager : Camber Pharmaceuticals Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Oxycodone HydrochlorideOxycodone Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-917
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 HYDROCHLORIDE15 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE(UNII: J2B2A4N98G)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color yellow Score 2
Shape ROUND Size 5 mm
Flavor Imprint Code T;188
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:31722-917-01100 in 1 BOTTLE Type 0: Not a Combination Product08/08/2017
2NDC:31722-917-05500 in 1 BOTTLE Type 0: Not a Combination Product08/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207418 08/08/2017
Oxycodone HydrochlorideOxycodone Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31722-918
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 HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTOSE(UNII: J2B2A4N98G)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color yellow Score 2
Shape ROUND Size 7 mm
Flavor Imprint Code T;189
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:31722-918-01100 in 1 BOTTLE Type 0: Not a Combination Product08/08/2017
2NDC:31722-918-05500 in 1 BOTTLE Type 0: Not a Combination Product08/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207418 08/08/2017

LABELER - Camber Pharmaceuticals Inc(826774775)

Establishment
Name Address ID/FEI Business Operations
Ascent Pharmaceuticals Inc 080938961 analysis(31722-917, 31722-918), manufacture(31722-917, 31722-918), pack(31722-917, 31722-918)

PRINCIPAL DISPLAY PANEL

15mg

15mg