OXYCODONE HCL

Manufacturing Establishments (1)

Labeler

DIRECT RX

DUNS Number

079254320

NDC Product Code

61919-659

Application Number

ANDA090659

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 21, 2020

Ingredients

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Code: C1ENJ2TE6CClass: ACTIBQuantity: 15 mg in 1 1