renacidin

Generic: citric acid, gluconolactone and magnesium carbonate

Labeler: united-guardian, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name renacidin
Generic Name citric acid, gluconolactone and magnesium carbonate
Labeler united-guardian, inc.
Dosage Form SOLUTION
Routes
IRRIGATION
Active Ingredients

anhydrous citric acid 6.602 g/100mL, gluconolactone .198 g/100mL, magnesium carbonate 3.268 g/100mL

Manufacturer
United-Guardian, Inc.

Identifiers & Regulatory

Product NDC 0327-0012
Product ID 0327-0012_73bb8d15-8d5c-426c-b42f-504a5da9cb8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019481
Listing Expiration 2026-12-31
Marketing Start 2016-02-01

Pharmacologic Class

Established (EPC)
calculi dissolution agent [epc] anti-coagulant [epc]
Mechanism of Action
acidifying activity [moa] calcium chelating activity [moa] irrigation [moa]
Physiologic Effect
decreased coagulation factor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03270012
Hyphenated Format 0327-0012

Supplemental Identifiers

RxCUI
1792396 1792398
UNII
XF417D3PSL WQ29KQ9POT 0E53J927NA
NUI
N0000175833 N0000175835 N0000175980 N0000008556 N0000175089 N0000175534

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name renacidin (source: ndc)
Generic Name citric acid, gluconolactone and magnesium carbonate (source: ndc)
Application Number NDA019481 (source: ndc)
Routes
IRRIGATION
source: ndc

Resolved Composition

Strengths
  • 6.602 g/100mL
  • .198 g/100mL
  • 3.268 g/100mL
source: ndc
Packaging
  • 30 BOTTLE in 1 CARTON (0327-0012-30) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

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

Ingredients (3)

anhydrous citric acid (6.602 g/100mL) gluconolactone (.198 g/100mL) magnesium carbonate (3.268 g/100mL)

Linked Drug Pages (1)

Renacidin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["IRRIGATION"], "spl_id": "73bb8d15-8d5c-426c-b42f-504a5da9cb8e", "openfda": {"nui": ["N0000175833", "N0000175835", "N0000175980", "N0000008556", "N0000175089", "N0000175534"], "unii": ["XF417D3PSL", "WQ29KQ9POT", "0E53J927NA"], "rxcui": ["1792396", "1792398"], "spl_set_id": ["13a9bbba-db21-4cba-991c-5d8afaf2ed74"], "pharm_class_pe": ["Decreased Coagulation Factor Activity [PE]"], "pharm_class_epc": ["Calculi Dissolution Agent [EPC]", "Anti-coagulant [EPC]"], "pharm_class_moa": ["Acidifying Activity [MoA]", "Calcium Chelating Activity [MoA]", "Irrigation [MoA]"], "manufacturer_name": ["United-Guardian, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BOTTLE in 1 CARTON (0327-0012-30)  / 30 mL in 1 BOTTLE", "package_ndc": "0327-0012-30", "marketing_start_date": "20160201"}], "brand_name": "Renacidin", "product_id": "0327-0012_73bb8d15-8d5c-426c-b42f-504a5da9cb8e", "dosage_form": "SOLUTION", "pharm_class": ["Acidifying Activity [MoA]", "Anti-coagulant [EPC]", "Calcium Chelating Activity [MoA]", "Calculi Dissolution Agent [EPC]", "Calculi Dissolution Agent [EPC]", "Decreased Coagulation Factor Activity [PE]", "Irrigation [MoA]"], "product_ndc": "0327-0012", "generic_name": "citric acid, gluconolactone and magnesium carbonate", "labeler_name": "United-Guardian, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Renacidin", "active_ingredients": [{"name": "ANHYDROUS CITRIC ACID", "strength": "6.602 g/100mL"}, {"name": "GLUCONOLACTONE", "strength": ".198 g/100mL"}, {"name": "MAGNESIUM CARBONATE", "strength": "3.268 g/100mL"}], "application_number": "NDA019481", "marketing_category": "NDA", "marketing_start_date": "20160201", "listing_expiration_date": "20261231"}