FDA Product

Metadate CD

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Metadate CD

FDA Product Code

54868-0668

Regulatory Information

NDC Product Code

54868-0668

Application Number

NDA021259

Marketing Category

C73594

Effective Date

March 3, 2011

Territorial Authority

USA

FDA Title

Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules CII

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerPhysicians Total Care, Inc.

DUNS Number

194123980

Active Ingredients

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

METHYLPHENIDATE HYDROCHLORIDE

Quantity: 30 mg in 1 1

Code: 4B3SC438HI

Class Code: ACTIB

POLYETHYLENE GLYCOL

Code: 3WJQ0SDW1A

Class Code: IACT

ETHYLCELLULOSES

Code: 7Z8S9VYZ4B

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

DIBUTYL SEBACATE

Code: 4W5IH7FLNY

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

Active Moieties

METHYLPHENIDATE

Code: 207ZZ9QZ49

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