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
NDC Product Code46287-014
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateDecember 2, 2020
Generic NameCitric Acid and Sodium Citrate
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