potassium citrate

Generic: potassium citrate

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name potassium citrate
Generic Name potassium citrate
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

potassium citrate 15 meq/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-538
Product ID 68382-538_b0382b88-fcc4-44de-b66d-a93dabc596f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203546
Listing Expiration 2026-12-31
Marketing Start 2014-08-12

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 68382538
Hyphenated Format 68382-538

Supplemental Identifiers

RxCUI
199376 199381 898490
UNII
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 (source: ndc)
Generic Name potassium citrate (source: ndc)
Application Number ANDA203546 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 meq/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-05)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-06)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-10)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-16)
  • 10 BLISTER PACK in 1 CARTON (68382-538-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (6)

68382-538-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-01) 68382-538-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-05) 68382-538-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-06) 68382-538-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-10) 68382-538-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-16) 68382-538-30 10 BLISTER PACK in 1 CARTON (68382-538-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

potassium citrate (15 meq/1)

Linked Drug Pages (1)

Potassium Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b0382b88-fcc4-44de-b66d-a93dabc596f8", "openfda": {"unii": ["EE90ONI6FF"], "rxcui": ["199376", "199381", "898490"], "spl_set_id": ["1a839f91-9bbd-4f46-b350-c5e8074b5db7"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-01)", "package_ndc": "68382-538-01", "marketing_start_date": "20140812"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-05)", "package_ndc": "68382-538-05", "marketing_start_date": "20140812"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-06)", "package_ndc": "68382-538-06", "marketing_start_date": "20140812"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-10)", "package_ndc": "68382-538-10", "marketing_start_date": "20140812"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-538-16)", "package_ndc": "68382-538-16", "marketing_start_date": "20140812"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-538-30)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "68382-538-30", "marketing_start_date": "20140812"}], "brand_name": "Potassium Citrate", "product_id": "68382-538_b0382b88-fcc4-44de-b66d-a93dabc596f8", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Acidifying Activity [MoA]", "Anti-coagulant [EPC]", "Calcium Chelating Activity [MoA]", "Calculi Dissolution Agent [EPC]", "Decreased Coagulation Factor Activity [PE]"], "product_ndc": "68382-538", "generic_name": "Potassium Citrate", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Potassium Citrate", "active_ingredients": [{"name": "POTASSIUM CITRATE", "strength": "15 meq/1"}], "application_number": "ANDA203546", "marketing_category": "ANDA", "marketing_start_date": "20140812", "listing_expiration_date": "20261231"}