Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Insulin Lispro Junior KwikPen
Product Details
NDC Product Code
0002-7752Application Number
BLA020563Marketing Category
BLA (C73585)Route of Administration
SUBCUTANEOUSEffective Date
July 21, 2023GlycerinInactive
Code: PDC6A3C0OXClass: IACTQuantity: 16 mg in 1 mL
MetacresolInactive
Code: GGO4Y809LOClass: IACTQuantity: 3.15 mg in 1 mL
Insulin LisproActive
Code: GFX7QIS1IIClass: ACTIBQuantity: 100 [iU] in 1 mL
PhenolInactive
Code: 339NCG44TVClass: IACT
Sodium Phosphate, Dibasic, Unspecified FormInactive
Code: GR686LBA74Class: IACTQuantity: 1.88 mg in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
Hydrochloric acidInactive
Code: QTT17582CBClass: IACT
ZincInactive
Code: J41CSQ7QDSClass: IACTQuantity: .0197 mg in 1 mL
Insulin Lispro KwikPen
Product Details
NDC Product Code
0002-8222Application Number
BLA020563Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
July 21, 2023GlycerinInactive
Code: PDC6A3C0OXClass: IACTQuantity: 16 mg in 1 mL
Insulin LisproActive
Code: GFX7QIS1IIClass: ACTIBQuantity: 100 [iU] in 1 mL
Sodium Phosphate, Dibasic, Unspecified FormInactive
Code: GR686LBA74Class: IACTQuantity: 1.88 mg in 1 mL
MetacresolInactive
Code: GGO4Y809LOClass: IACTQuantity: 3.15 mg in 1 mL
ZincInactive
Code: J41CSQ7QDSClass: IACTQuantity: .0197 mg in 1 mL
PhenolInactive
Code: 339NCG44TVClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
Hydrochloric acidInactive
Code: QTT17582CBClass: IACT
Insulin Lispro
Product Details
NDC Product Code
0002-7737Application Number
BLA020563Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
July 21, 2023Insulin LisproActive
Code: GFX7QIS1IIClass: ACTIBQuantity: 100 [iU] in 1 mL
Sodium Phosphate, Dibasic, Unspecified FormInactive
Code: GR686LBA74Class: IACTQuantity: 1.88 mg in 1 mL
GlycerinInactive
Code: PDC6A3C0OXClass: IACTQuantity: 16 mg in 1 mL
ZincInactive
Code: J41CSQ7QDSClass: IACTQuantity: .0197 mg in 1 mL
PhenolInactive
Code: 339NCG44TVClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
MetacresolInactive
Code: GGO4Y809LOClass: IACTQuantity: 3.15 mg in 1 mL
Hydrochloric acidInactive
Code: QTT17582CBClass: IACT