Pacerone

Manufacturing Establishments1

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

Labeler

Aphena Pharma Solutions - Tennessee, LLC

DUNS Number

128385585

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

NDC Product Code

67544-570

Application Number

ANDA075135

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 9, 2014

Ingredients

Code: 976728SY6ZClass: ACTIBQuantity: 200 mg in 1 1

lactose monohydrateInactive

Code: EWQ57Q8I5XClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

sodium starch glycolate type a potatoInactive

Code: 5856J3G2A2Class: IACT

povidone, unspecifiedInactive

Code: FZ989GH94EClass: IACT

starch, cornInactive

Code: O8232NY3SJClass: IACT

stearic acidInactive

Code: 4ELV7Z65APClass: IACT

FD&C Red No. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT