Sodium Citrate and Citric Acid

Product NDC
50268-183
11-digit product format
502680183
Labeler code
50268
Product ID
50268-183_2b48bae3-c39f-1035-e063-6394a90a2cc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Dosage form
SOLUTION
Route
ORAL
Labeler
AvPAK
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-06-13
Substance
ANHYDROUS CITRIC ACID; SODIUM CITRATE
Active strength
334; 500 mg/5mL; mg/5mL
Pharmacologic classes
Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
XF417D3PSLANHYDROUS CITRIC ACID77-92-9ANHYDROUS CITRIC ACID

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50268-183-305026801833040 CUP, UNIT-DOSE in 1 CARTON (50268-183-30) / 30 mL in 1 CUP, UNIT-DOSE (50268-183-11) 2023-06-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sodium Citrate and Citric Acid Oral Solution USPAvPAK2025-01-09HUMAN PRESCRIPTION DRUG LABEL2