Home NDC 46287-014 Oracit
Product NDC 46287-014
11-digit product format 462870014
Labeler code 46287
Product ID 46287-014_8691f6bc-18e9-4336-8e10-c702ecace00a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Citric Acid and Sodium Citrate
Dosage form SOLUTION
Route ORAL
Labeler CMP Pharma, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1984-05-15
Substance CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE
Active strength 640; 490 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 Additional Listing Data#
Finished product Yes
Brand name base Oracit
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CITRIC ACID MONOHYDRATE 640 mg/5mL TRISODIUM CITRATE DIHYDRATE 490 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2968PHW8QP Internal UNII lookup B22547B95K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 544550 Internal RxNorm lookup 544553 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46287-014-01 Oracit 500 mL in 1 BOTTLE SOLUTION 500 5 46287-014-15 Oracit 15 mL in 1 BOTTLE, UNIT-DOSE SOLUTION 15 5 46287-014-15 Oracit 10 in 1 CARTON SOLUTION 10 5 46287-014-30 Oracit 30 mL in 1 BOTTLE, UNIT-DOSE SOLUTION 30 5 46287-014-30 Oracit 10 in 1 CARTON SOLUTION 10 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46287-014 ORACIT (CITRIC ACID AND SODIUM CITRATE) SOLUTION [CMP PHARMA, INC.] 5 Current NDC, Legacy NDC, 5 package rows 20231208_bc26abed-8e6e-475d-8ab3-abf7d0377003.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oracit CITRIC ACID AND SODIUM CITRATE CMP Pharma, Inc. bc26abed-8e6e-475d-8ab3-abf7d0377003 2023-12-07 Adverse reactions Exact identifier ndc (product): 46287-014
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 46287-014-01 46287001401 500 mL in 1 BOTTLE (46287-014-01) 500 ml 1984-05-15 0000-00-00 No No Current 46287-014-15 46287001415 10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-15) / 15 mL in 1 BOTTLE, UNIT-DOSE 1984-05-15 0000-00-00 No No Current 46287-014-30 46287001430 10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-30) / 30 mL in 1 BOTTLE, UNIT-DOSE 1984-05-15 0000-00-00 No No Current