Sodium Citrate and Citric Acid

Product NDC
69367-320
11-digit product format
693670320
Labeler code
69367
Product ID
69367-320_b91f33e5-b59b-4c7f-ae33-802b2238deba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium citrate and citric acid monohydrate
Dosage form
SOLUTION
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-07-20
Marketing end
0000-00-00
Substance
SODIUM CITRATE, UNSPECIFIED FORM; ANHYDROUS CITRIC ACID
Active strength
500 mg/5mL; mg/5mL
Pharmacologic 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
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-320-16ML - Milliliter69367-32055d0696a-9f88-4503-a690-ecec37d226c312021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-320-1669367032016473 mL in 1 BOTTLE (69367-320-16) 473 ml2021-07-200000-00-00NoNoCurrent