NDC 46287-014

Oracit

Citric Acid And Sodium Citrate

Oracit is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Cmp Pharma, Inc.. The primary component is Citric Acid Monohydrate; Trisodium Citrate Dihydrate.

• Product ID: 46287-014_451b0304-847a-41b2-a5d6-8574ce414148
• NDC: 46287-014
• Product Type: Human Prescription Drug
• Proprietary Name: Oracit
• Generic Name: Citric Acid And Sodium Citrate
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 1984-05-15
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: CMP Pharma, Inc.
• Substance Name: CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE
• Active Ingredient Strength: 640 mg/5mL; mg/5mL
• Pharm Classes: Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 46287-014-01

500 mL in 1 BOTTLE (46287-014-01)

• Marketing Start Date: 1984-05-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46287-014-15 [46287001415]

Oracit SOLUTION

• Marketing Category: Unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1984-05-15

NDC 46287-014-01 [46287001401]

Oracit SOLUTION

• Marketing Category: Unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1984-05-15

NDC 46287-014-30 [46287001430]

Oracit SOLUTION

• Marketing Category: Unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1984-05-15

Drug Details

Active Ingredients

Ingredient	Strength
CITRIC ACID MONOHYDRATE	640 mg/5mL

OpenFDA Data

• SPL SET ID: bc26abed-8e6e-475d-8ab3-abf7d0377003
• Manufacturer:
  • CMP Pharma, Inc.
• UNII:
  • 2968PHW8QP
  • B22547B95K
• RxNorm Concept Unique ID - RxCUI:
  • 544553
  • 544550
• UPC Code:
  • 0346287014010

Pharmacological Class

• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]
• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]
• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]
• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]