Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
RPK Pharmaceuticals, Inc.
RPK Pharmaceuticals, Inc.
147096275
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ciprofloxacin
Product Details
NDC Product Code
53002-2790Application Number
ANDA076639Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 5, 2022CiprofloxacinActive
Code: 4BA73M5E37Class: ACTIMQuantity: 250 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ciprofloxacin
Product Details
NDC Product Code
53002-2640Application Number
ANDA076639Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 5, 2022CiprofloxacinActive
Code: 4BA73M5E37Class: ACTIMQuantity: 500 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT