potassium citrate and citric acid

Generic: potassium citrate and citric acid

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name potassium citrate and citric acid
Generic Name potassium citrate and citric acid
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

citric acid monohydrate 334 mg/5mL, potassium citrate 1100 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-435
Product ID 62135-435_32598dec-73a0-13fd-e063-6294a90ad1ce
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 62135435
Hyphenated Format 62135-435

Supplemental Identifiers

RxCUI
309318
UPC
0362135435479
UNII
2968PHW8QP EE90ONI6FF

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 potassium citrate and citric acid (source: ndc)
Generic Name potassium citrate and citric acid (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 334 mg/5mL
  • 1100 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-435-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-435-05)
  • 473 mL in 1 BOTTLE (62135-435-47)
source: ndc

Packages (2)

62135-435-24 2 TRAY in 1 BOX (62135-435-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-435-05) 62135-435-47 473 mL in 1 BOTTLE (62135-435-47)

Ingredients (2)

citric acid monohydrate (334 mg/5mL) potassium citrate (1100 mg/5mL)

Linked Drug Pages (1)

Potassium Citrate and Citric Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32598dec-73a0-13fd-e063-6294a90ad1ce", "openfda": {"upc": ["0362135435479"], "unii": ["2968PHW8QP", "EE90ONI6FF"], "rxcui": ["309318"], "spl_set_id": ["978a5a9d-f0ca-4308-a84b-3b132263bbb8"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-435-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-435-05)", "package_ndc": "62135-435-24", "marketing_start_date": "20250404"}, {"sample": false, "description": "473 mL in 1 BOTTLE (62135-435-47)", "package_ndc": "62135-435-47", "marketing_start_date": "20221208"}], "brand_name": "Potassium Citrate and Citric Acid", "product_id": "62135-435_32598dec-73a0-13fd-e063-6294a90ad1ce", "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": "62135-435", "generic_name": "Potassium Citrate and Citric Acid", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Potassium Citrate and Citric Acid", "active_ingredients": [{"name": "CITRIC ACID MONOHYDRATE", "strength": "334 mg/5mL"}, {"name": "POTASSIUM CITRATE", "strength": "1100 mg/5mL"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20221208", "listing_expiration_date": "20261231"}