potassium chloride

Generic: potassium chloride

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

Drug Facts

Product Profile

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

potassium chloride 600 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-853
Product ID 68382-853_37302db1-d7cc-4b79-8b3e-f14d40342ef4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208445
Listing Expiration 2026-12-31
Marketing Start 2019-06-30

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 68382853
Hyphenated Format 68382-853

Supplemental Identifiers

RxCUI
312504 315183
UPC
0368382853011 0368382854018
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 ANDA208445 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-853-01)
  • 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-853-05)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-853-10)
  • 10 BLISTER PACK in 1 CARTON (68382-853-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-853-30)
source: ndc

Packages (4)

68382-853-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-853-01) 68382-853-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-853-05) 68382-853-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-853-10) 68382-853-77 10 BLISTER PACK in 1 CARTON (68382-853-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-853-30)

Ingredients (1)

potassium chloride (600 mg/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": "37302db1-d7cc-4b79-8b3e-f14d40342ef4", "openfda": {"upc": ["0368382853011", "0368382854018"], "unii": ["660YQ98I10"], "rxcui": ["312504", "315183"], "spl_set_id": ["51586c47-1aff-4ce6-8030-89f9eb1bc9ac"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-853-01)", "package_ndc": "68382-853-01", "marketing_start_date": "20190630"}, {"sample": false, "description": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-853-05)", "package_ndc": "68382-853-05", "marketing_start_date": "20190630"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-853-10)", "package_ndc": "68382-853-10", "marketing_start_date": "20190630"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-853-77)  / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-853-30)", "package_ndc": "68382-853-77", "marketing_start_date": "20190630"}], "brand_name": "potassium chloride", "product_id": "68382-853_37302db1-d7cc-4b79-8b3e-f14d40342ef4", "dosage_form": "CAPSULE, 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": "68382-853", "generic_name": "potassium chloride", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "potassium chloride", "active_ingredients": [{"name": "POTASSIUM CHLORIDE", "strength": "600 mg/1"}], "application_number": "ANDA208445", "marketing_category": "ANDA", "marketing_start_date": "20190630", "listing_expiration_date": "20261231"}