Oracit
ORACIT Oral Citrate (Shohl's) SolutionCMP Pharma, Inc.
Approved
Approval ID
bc26abed-8e6e-475d-8ab3-abf7d0377003
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2023
Manufacturers
FDA
CMP Pharma, Inc.
DUNS: 005224175
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Citric Acid and Sodium Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46287-014
Product Classification
G
Generic Name
Citric Acid and Sodium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2020
FDA Product Classification
INGREDIENTS (5)
CITRIC ACID MONOHYDRATEActive
Quantity: 640 mg in 5 mL
Code: 2968PHW8QP
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TRISODIUM CITRATE DIHYDRATEActive
Quantity: 490 mg in 5 mL
Code: B22547B95K
Classification: ACTIM