Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Proficient Rx LP
Proficient Rx LP
079196022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Potassium chloride extended release
Product Details
NDC Product Code
71205-996Application Number
ANDA205993Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 1, 2022Potassium chlorideActive
Code: 660YQ98I10Class: ACTIBQuantity: 750 mg in 1 1
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EAClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT