Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PRM Pharma LLC
118256253
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Ingenus Pharmaceuticals NJ, LLC
Ingenus Pharmaceuticals, LLC
PRM Pharma LLC
964680206
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HEMICLOR
Product Details
NDC Product Code
50742-285Application Number
NDA218647Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 27, 2025SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ChlorthalidoneActive
Code: Q0MQD1073QClass: ACTIBQuantity: 12.5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4DClass: IACT
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT