71321-604 NDC - ORAL CITRATE SOLUTION (CITRIC ACID AND SODIUM CITRATE)

Drug Information

  • Product NDC: 71321-604
  • Proprietary Name: Oral Citrate Solution
  • Non Proprietary Name: Citric Acid and Sodium Citrate
  • Active Ingredient(s): 640 mg/5mL CITRIC ACID MONOHYDRATE; 490 mg/5mL TRISODIUM CITRATE DIHYDRATE
  • Administration Route(s): ORAL
  • Dosage Form(s): SOLUTION
  • Pharmacy Class(es): 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]

Labeler Information

Field Name Field Value
Labeler Name: Brandywine Pharmaceuticals, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:2/21/2024
End Marketing Date:2/12/2026

Package Information

No. Package Code Package Description Billing Unit
171321-604-16473 mL in 1 BOTTLE (71321-604-16)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC71321-604The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEOral Citrate SolutionThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECitric Acid and Sodium CitrateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/21/2024This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE2/12/2026This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEBrandywine Pharmaceuticals, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH640; 490 
ACTIVE INGRED UNITmg/5mL; mg/5mL 
PHARM CLASSESAcidifying 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] 

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This page was last updated on: 7/4/2025

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