Propoxyphene and Acetaminophen

Manufacturing Establishments1

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

Altura Pharmaceuticals, Inc.

Labeler

Altura Pharmaceuticals, Inc.

DUNS Number

006890545

Products1

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

Product Details

NDC Product Code

63874-201

Application Number

ANDA074843

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 28, 2010

Ingredients

Propoxyphene NapsylateActive

Code: 38M219L1OJClass: ACTIBQuantity: 100 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZClass: IACT

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 650 mg in 1 1

HYPROMELLOSEInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

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Propoxyphene and Acetaminophen

FDA Approval Summary

Manufacturing Establishments1

Products1

Propoxyphene and Acetaminophen

Product Details