sodium citrate and citric acid

Generic: sodium citrate and citric acid monohydrate

Labeler: avpak
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 avpak
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-183
Product ID 50268-183_2b48bae3-c39f-1035-e063-6394a90a2cc8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2023-06-13

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 50268183
Hyphenated Format 50268-183

Supplemental Identifiers

RxCUI
543014
UNII
1Q73Q2JULR XF417D3PSL
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
  • 40 CUP, UNIT-DOSE in 1 CARTON (50268-183-30) / 30 mL in 1 CUP, UNIT-DOSE (50268-183-11)
source: ndc

Packages (1)

50268-183-30 40 CUP, UNIT-DOSE in 1 CARTON (50268-183-30) / 30 mL in 1 CUP, UNIT-DOSE (50268-183-11)

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": "2b48bae3-c39f-1035-e063-6394a90a2cc8", "openfda": {"nui": ["N0000175833", "N0000175835", "N0000175980", "N0000008556", "N0000175089"], "unii": ["1Q73Q2JULR", "XF417D3PSL"], "rxcui": ["543014"], "spl_set_id": ["fe070e2e-3e72-fb84-e053-6294a90afd88"], "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": ["AvPAK"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 CUP, UNIT-DOSE in 1 CARTON (50268-183-30)  / 30 mL in 1 CUP, UNIT-DOSE (50268-183-11)", "package_ndc": "50268-183-30", "marketing_start_date": "20230613"}], "brand_name": "Sodium Citrate and Citric Acid", "product_id": "50268-183_2b48bae3-c39f-1035-e063-6394a90a2cc8", "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": "50268-183", "generic_name": "SODIUM CITRATE and CITRIC ACID MONOHYDRATE", "labeler_name": "AvPAK", "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": "20230613", "listing_expiration_date": "20261231"}