sodium citrate and citric acid

Generic: sodium citrate and citric acid monohydrate

Labeler: belleview biosciences llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name sodium citrate and citric acid
Generic Name sodium citrate and citric acid monohydrate
Labeler belleview biosciences llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

anhydrous citric acid 334 mg/5mL, sodium citrate 500 mg/5mL

Manufacturer
Belleview Biosciences LLC

Identifiers & Regulatory

Product NDC 84447-017
Product ID 84447-017_395a52e7-d488-26c6-e063-6394a90a8158
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2025-04-08

Pharmacologic Class

Established (EPC)
calculi dissolution agent [epc] anti-coagulant [epc]
Mechanism of Action
acidifying activity [moa] calcium chelating activity [moa]
Physiologic Effect
decreased coagulation factor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84447017
Hyphenated Format 84447-017

Supplemental Identifiers

RxCUI
543014
UNII
XF417D3PSL 1Q73Q2JULR
NUI
N0000175833 N0000175835 N0000175980 N0000008556 N0000175089

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sodium citrate and citric acid (source: ndc)
Generic Name sodium citrate and citric acid monohydrate (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 334 mg/5mL
  • 500 mg/5mL
source: ndc
Packaging
  • 200000 mL in 1 DRUM (84447-017-01)
source: ndc

Packages (1)

84447-017-01 200000 mL in 1 DRUM (84447-017-01)

Ingredients (2)

anhydrous citric acid (334 mg/5mL) sodium citrate (500 mg/5mL)

Linked Drug Pages (1)

Sodium Citrate and Citric Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "395a52e7-d488-26c6-e063-6394a90a8158", "openfda": {"nui": ["N0000175833", "N0000175835", "N0000175980", "N0000008556", "N0000175089"], "unii": ["XF417D3PSL", "1Q73Q2JULR"], "rxcui": ["543014"], "spl_set_id": ["3245e0e5-5e7f-c3f7-e063-6394a90ac258"], "pharm_class_pe": ["Decreased Coagulation Factor Activity [PE]"], "pharm_class_epc": ["Calculi Dissolution Agent [EPC]", "Anti-coagulant [EPC]"], "pharm_class_moa": ["Acidifying Activity [MoA]", "Calcium Chelating Activity [MoA]"], "manufacturer_name": ["Belleview Biosciences LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200000 mL in 1 DRUM (84447-017-01)", "package_ndc": "84447-017-01", "marketing_start_date": "20250408"}], "brand_name": "Sodium Citrate and Citric Acid", "product_id": "84447-017_395a52e7-d488-26c6-e063-6394a90a8158", "dosage_form": "SOLUTION", "pharm_class": ["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]"], "product_ndc": "84447-017", "generic_name": "SODIUM CITRATE and CITRIC ACID MONOHYDRATE", "labeler_name": "Belleview Biosciences LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Citrate and Citric Acid", "active_ingredients": [{"name": "ANHYDROUS CITRIC ACID", "strength": "334 mg/5mL"}, {"name": "SODIUM CITRATE", "strength": "500 mg/5mL"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20250408", "listing_expiration_date": "20261231"}