Acetaminophen and Codeine Phosphate

Manufacturing Establishments1

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

NuCare Pharmaceuticals, Inc.

Labeler

NuCare Pharmaceuticals, Inc.

DUNS Number

010632300

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

68071-3061

Application Number

ANDA202800

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 10, 2021

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 1 1

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CodeineActive

Code: GSL05Y1MN6Class: ACTIBQuantity: 30 mg in 1 1

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Acetaminophen and Codeine Phosphate

FDA Approval Summary

Manufacturing Establishments1

Products1

Acetaminophen and Codeine Phosphate

Product Details