DRONABINOL

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Pharmaceutics International, Inc

Labeler

Rhodes Pharmaceuticals L.P.

DUNS Number

878265586

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

42858-868

Application Number

ANDA078292

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 31, 2023

Ingredients

DronabinolActive

Code: 7J8897W37SClass: ACTIBQuantity: 5 mg in 1 1

FD&C Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT

Gelatin, unspecifiedInactive

Code: 2G86QN327LClass: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

GlycerinInactive

Code: PDC6A3C0OXClass: IACT

Titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Sesame OilInactive

Code: QX10HYY4QVClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Isopropyl alcoholInactive

Code: ND2M416302Class: IACT

Propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

Butyl alcoholInactive

Code: 8PJ61P6TS3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FD&C Red No. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

DRONABINOL

Product Details

NDC Product Code

42858-867

Application Number

ANDA078292

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 31, 2023

Ingredients

FD&C Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT

Gelatin, unspecifiedInactive

Code: 2G86QN327LClass: IACT

DronabinolActive

Code: 7J8897W37SClass: ACTIBQuantity: 2.5 mg in 1 1

GlycerinInactive

Code: PDC6A3C0OXClass: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

Sesame OilInactive

Code: QX10HYY4QVClass: IACT

Titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Isopropyl alcoholInactive

Code: ND2M416302Class: IACT

Butyl alcoholInactive

Code: 8PJ61P6TS3Class: IACT

Propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

FD&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C Red No. 40Inactive

Code: WZB9127XOAClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

DRONABINOL

Product Details

NDC Product Code

42858-869

Application Number

ANDA078292

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 31, 2023

Ingredients

DronabinolActive

Code: 7J8897W37SClass: ACTIBQuantity: 10 mg in 1 1

Gelatin, unspecifiedInactive

Code: 2G86QN327LClass: IACT

FD&C Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT

GlycerinInactive

Code: PDC6A3C0OXClass: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

Sesame OilInactive

Code: QX10HYY4QVClass: IACT

Titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Isopropyl alcoholInactive

Code: ND2M416302Class: IACT

Butyl alcoholInactive

Code: 8PJ61P6TS3Class: IACT

Propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

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DRONABINOL

FDA Approval Summary

Manufacturing Establishments1

Products3

DRONABINOL

Product Details

DRONABINOL

Product Details

DRONABINOL

Product Details