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Oxycodone Hydrochloride (Page 5 of 5)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (100 Tablet Bottle)

NDC 13107-055-01
Oxycodone Hydrochloride Tablets, USP CII
5 mg
Rx only 100 Tablets AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5 mg (100 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 15 mg (100 Tablet Bottle)

NDC 13107-056-01
Oxycodone Hydrochloride Tablets, USP CII
15 mg
Rx only 100 Tablets AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 15 mg (100 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 30 mg (100 Tablet Bottle)

NDC 13107-057-01
Oxycodone Hydrochloride Tablets, USP CII
30 mg
Rx only 100 Tablets
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 30 mg (100 Tablet Bottle)
(click image for full-size original)

OXYCODONE HYDROCHLORIDE oxycodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13107-055
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
LACTOSE MONOHYDRATE
ANHYDROUS LACTOSE
STARCH, CORN
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code U22
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13107-055-30 30 TABLET in 1 BOTTLE None
2 NDC:13107-055-01 100 TABLET in 1 BOTTLE None
3 NDC:13107-055-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202160 07/12/2012
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13107-056
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
LACTOSE MONOHYDRATE
ANHYDROUS LACTOSE
STARCH, CORN
FD&C BLUE NO. 2
D&C YELLOW NO. 10
Product Characteristics
Color GREEN (Light green to green) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code U23
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13107-056-30 30 TABLET in 1 BOTTLE None
2 NDC:13107-056-01 100 TABLET in 1 BOTTLE None
3 NDC:13107-056-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202160 07/12/2012
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13107-057
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
LACTOSE MONOHYDRATE
ANHYDROUS LACTOSE
STARCH, CORN
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (Light blue to blue) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code U24
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13107-057-30 30 TABLET in 1 BOTTLE None
2 NDC:13107-057-01 100 TABLET in 1 BOTTLE None
3 NDC:13107-057-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202160 07/12/2012
Labeler — Aurolife Pharma LLC (829084461)
Establishment
Name Address ID/FEI Operations
Aurolife Pharma LLC 829084461 MANUFACTURE (13107-055), MANUFACTURE (13107-056), MANUFACTURE (13107-057)

Revised: 11/2011 Aurolife Pharma LLC

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