Hydrocodone Polistirex and Chlorpheniramine Polistirex

These highlights do not include all the information needed to use Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension safely and effectively. See full prescribing information for Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, for oral administration, CII Initial U.S. Approval: 1987

Approved

Approval ID

eecaa52b-f636-4ae4-a60f-d5e2503ab53b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 20, 2023

Manufacturers

FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

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

Hydrocodone Polistirex and Chlorpheniramine Polistirex

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code63629-2304

Application NumberANDA091632

Product Classification

Marketing Category

C73584

Generic Name

Hydrocodone Polistirex and Chlorpheniramine Polistirex

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 6, 2022

FDA Product Classification

INGREDIENTS (18)

HYDROCODONE BITARTRATEActive

Quantity: 10 mg in 5 mL

Code: NO70W886KK

Classification: ACTIB

CHLORPHENIRAMINE MALEATEActive

Quantity: 8 mg in 5 mL

Code: V1Q0O9OJ9Z

Classification: ACTIB

ASCORBIC ACIDInactive

Code: PQ6CK8PD0R

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

HIGH FRUCTOSE CORN SYRUPInactive

Code: XY6UN3QB6S

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

POLYVINYL ACETATEInactive

Code: 32K497ZK2U

Classification: IACT

SODIUM ASCORBATEInactive

Code: S033EH8359

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3C

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

SODIUM POLYSTYRENE SULFONATEInactive

Code: 1699G8679Z

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OH

Classification: IACT

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Hydrocodone Polistirex and Chlorpheniramine Polistirex

Products 1

Hydrocodone Polistirex and Chlorpheniramine Polistirex

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

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Company

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