NDC 0327-0012

Renacidin

Citric Acid, Gluconolactone And Magnesium Carbonate

Renacidin is a Irrigation Solution in the Human Prescription Drug category. It is labeled and distributed by United-guardian, Inc.. The primary component is Anhydrous Citric Acid; Gluconolactone; Magnesium Carbonate.

• Product ID: 0327-0012_3c4721a1-66c6-472a-ad22-d7813cb0c74c
• NDC: 0327-0012
• Product Type: Human Prescription Drug
• Proprietary Name: Renacidin
• Generic Name: Citric Acid, Gluconolactone And Magnesium Carbonate
• Dosage Form: Solution
• Route of Administration: IRRIGATION
• Marketing Start Date: 2016-02-01
• Marketing Category: NDA / NDA
• Application Number: NDA019481
• Labeler Name: United-Guardian, Inc.
• Substance Name: ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE
• Active Ingredient Strength: 7 g/100mL; g/100mL; g/100mL
• Pharm Classes: Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Irrigation [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0327-0012-30

30 BOTTLE in 1 CARTON (0327-0012-30) > 30 mL in 1 BOTTLE

• Marketing Start Date: 2016-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0327-0012-30 [00327001230]

Renacidin SOLUTION

• Marketing Category: NDA
• Application Number: NDA019481
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-02-01

Drug Details

Active Ingredients

Ingredient	Strength
ANHYDROUS CITRIC ACID	6.602 g/100mL

OpenFDA Data

• SPL SET ID: 13a9bbba-db21-4cba-991c-5d8afaf2ed74
• Manufacturer:
  • United-Guardian, Inc.
• UNII:
  • XF417D3PSL
  • 0E53J927NA
  • WQ29KQ9POT
• RxNorm Concept Unique ID - RxCUI:
  • 1792398
  • 1792396

Pharmacological Class

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