FDA.reportPublic FDA data

Renacidin

Product NDC
0327-0012
11-digit product format
003270012
Labeler code
0327
Product ID
0327-0012_73bb8d15-8d5c-426c-b42f-504a5da9cb8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
citric acid, gluconolactone and magnesium carbonate
Dosage form
SOLUTION
Route
IRRIGATION
Labeler
United-Guardian, Inc.
Application
NDA019481
Marketing category
NDA
Marketing start
2016-02-01
Substance
ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE
Active strength
6.602; .198; 3.268 g/100mL; g/100mL; g/100mL
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Renacidin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANHYDROUS CITRIC ACID6.602 g/100mL
GLUCONOLACTONE.198 g/100mL
MAGNESIUM CARBONATE3.268 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXF417D3PSL, WQ29KQ9POT, 0E53J927NA
Rxcui1792396, 1792398

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0327-0012-30Renacidin30 in 1 CARTONSOLUTION303
0327-0012-30Renacidin30 mL in 1 BOTTLESOLUTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0327-0012-30ML - Milliliter0327-00129a758ea9-cc27-4784-bf08-a37ed710593d12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0327-0012RENACIDIN (CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE) SOLUTION [UNITED-GUARDIAN, INC.]3Current NDC, Legacy NDC, 2 package rows20191231_13a9bbba-db21-4cba-991c-5d8afaf2ed74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1792396citric acid 1980.6 MG / gluconolactone 59.4 MG / magnesium carbonate 980.4 MG in 30 ML Irrigation SolutionPSN13a9bbba-db21-4cba-991c-5d8afaf2ed743
1792398RENACIDIN 1980.6 MG / 59.4 MG / 980.4 MG in 30 ML Irrigation SolutionPSN13a9bbba-db21-4cba-991c-5d8afaf2ed743
1792398citric acid 66 MG/ML / gluconolactone 1.98 MG/ML / magnesium carbonate 32.7 MG/ML Irrigation Solution [Renacidin]SBD13a9bbba-db21-4cba-991c-5d8afaf2ed743
1792396citric acid 66 MG/ML / gluconolactone 1.98 MG/ML / magnesium carbonate 32.7 MG/ML Irrigation SolutionSCD13a9bbba-db21-4cba-991c-5d8afaf2ed743
1792396citric acid 1980.6 MG / gluconolactone 59.4 MG / magnesium carbonate 980.4 MG per 30 ML Irrigation SolutionSY13a9bbba-db21-4cba-991c-5d8afaf2ed743
1792396citric acid 6.602 GM / gluconolactone 0.198 GM / magnesium carbonate 3.268 GM per 100 ML Irrigation SolutionSY13a9bbba-db21-4cba-991c-5d8afaf2ed743
1792398Renacidin (citric acid 1980.6 MG / gluconolactone 59.4 MG / magnesium carbonate 980.4 MG) per 30 ML Irrigation SolutionSY13a9bbba-db21-4cba-991c-5d8afaf2ed743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0327-0012-300032700123030 BOTTLE in 1 CARTON (0327-0012-30) / 30 mL in 1 BOTTLE30 bottle2016-02-010000-00-00NoNoCurrent