sodium citrate and citric acid

Generic: sodium citrate and citric acid

Labeler: chartwell rx, 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
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-434
Product ID 62135-434_19c45cf2-8b45-3d39-e063-6394a90a6e54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2022-12-08

Pharmacologic Class

Classes
acidifying activity [moa] anti-coagulant [epc] calcium chelating activity [moa] calculi dissolution agent [epc] decreased coagulation factor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135434
Hyphenated Format 62135-434

Supplemental Identifiers

RxCUI
543014
UPC
0362135434472
UNII
2968PHW8QP 1Q73Q2JULR

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 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 334 mg/5mL
  • 500 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (62135-434-47)
source: ndc

Packages (1)

62135-434-47 473 mL in 1 BOTTLE (62135-434-47)

Ingredients (2)

citric acid monohydrate (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": "19c45cf2-8b45-3d39-e063-6394a90a6e54", "openfda": {"upc": ["0362135434472"], "unii": ["2968PHW8QP", "1Q73Q2JULR"], "rxcui": ["543014"], "spl_set_id": ["525136c9-7758-437b-b57b-94b905786825"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (62135-434-47)", "package_ndc": "62135-434-47", "marketing_start_date": "20221208"}], "brand_name": "Sodium Citrate and Citric Acid", "product_id": "62135-434_19c45cf2-8b45-3d39-e063-6394a90a6e54", "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": "62135-434", "generic_name": "Sodium Citrate and Citric Acid", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Citrate and Citric Acid", "active_ingredients": [{"name": "CITRIC ACID MONOHYDRATE", "strength": "334 mg/5mL"}, {"name": "SODIUM CITRATE", "strength": "500 mg/5mL"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20221208", "listing_expiration_date": "20261231"}