potassium chloride

Generic: potassium chloride

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name potassium chloride
Generic Name potassium chloride
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

potassium chloride 10 meq/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4561
Product ID 0378-4561_a05e4397-8442-41d9-afa7-832163c3b554
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204662
Marketing Start 2016-11-09
Marketing End 2027-01-31

Pharmacologic Class

Classes
increased large intestinal motility [pe] inhibition large intestine fluid/electrolyte absorption [pe] osmotic activity [moa] osmotic laxative [epc] potassium compounds [cs] potassium salt [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03784561
Hyphenated Format 0378-4561

Supplemental Identifiers

RxCUI
312529 628953
UPC
0303784561775 0303784560778
UNII
660YQ98I10

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 chloride (source: ndc)
Generic Name potassium chloride (source: ndc)
Application Number ANDA204662 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 meq/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4561-05)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4561-77)
source: ndc

Packages (2)

0378-4561-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4561-05) 0378-4561-77 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4561-77)

Ingredients (1)

potassium chloride (10 meq/1)

Linked Drug Pages (1)

Potassium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a05e4397-8442-41d9-afa7-832163c3b554", "openfda": {"upc": ["0303784561775", "0303784560778"], "unii": ["660YQ98I10"], "rxcui": ["312529", "628953"], "spl_set_id": ["c64ed4c0-1e27-42b3-9625-fb4e0d31e271"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4561-05)", "package_ndc": "0378-4561-05", "marketing_end_date": "20270131", "marketing_start_date": "20161109"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4561-77)", "package_ndc": "0378-4561-77", "marketing_end_date": "20261130", "marketing_start_date": "20161109"}], "brand_name": "Potassium Chloride", "product_id": "0378-4561_a05e4397-8442-41d9-afa7-832163c3b554", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]", "Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Potassium Compounds [CS]", "Potassium Salt [EPC]"], "product_ndc": "0378-4561", "generic_name": "potassium chloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Potassium Chloride", "active_ingredients": [{"name": "POTASSIUM CHLORIDE", "strength": "10 meq/1"}], "application_number": "ANDA204662", "marketing_category": "ANDA", "marketing_end_date": "20270131", "marketing_start_date": "20161109"}