Label: OXYCODONE HCL tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 61919-659-60 - Packager: Direct RX
- This is a repackaged label.
- Source NDC Code(s): 57664-187
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: CII
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 8, 2016
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- Official Label (Printer Friendly)
- DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- CONTRAINDICATIONs
- WARNINGS
- PRECAUTIONS
- ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OXYCODONE HCL
oxycodone hcl tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-659(NDC:57664-187) 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 HYDROCHLORIDE 15 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Product Characteristics Color green Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code 187 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-659-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090659 02/08/2016 Labeler - Direct RX (079254320) Establishment Name Address ID/FEI Business Operations Direct RX 079254320 repack(61919-659)
