FDA Product

Oracit

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

Basic Information

Product Name

Oracit

FDA Product Code

46287-014

Regulatory Information

NDC Product Code

46287-014

Effective Date

December 2, 2020

FDA Title

ORACIT Oral Citrate (Shohl's) SolutionCMP Pharma, Inc.

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

5

Company Information

ManufacturerCMP Pharma, Inc.

DUNS Number

005224175

Active Ingredients

CITRIC ACID MONOHYDRATE

Quantity: 640 mg in 5 mL

Code: 2968PHW8QP

Class Code: ACTIM

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

TRISODIUM CITRATE DIHYDRATE

Quantity: 490 mg in 5 mL

Code: B22547B95K

Class Code: ACTIM

Active Moieties

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

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