Humalog
HUMALOG Mix75/25 75% INSULIN LISPRO PROTAMINE SUSPENSION AND25% INSULIN LISPRO INJECTION(rDNA ORIGIN)100 UNITS PER ML (U-100)
Approved
Approval ID
fbc1ff07-701e-4b7f-93a3-f4309e238e5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Insulin lispro
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4381
Application NumberNDA021017
Product Classification
M
Marketing Category
C73594
G
Generic Name
Insulin lispro
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 20, 2011
FDA Product Classification
INGREDIENTS (10)
sodium phosphate, dibasicInactive
Quantity: 3.78 mg in 1 mL
Code: GR686LBA74
Classification: IACT
Insulin lisproActive
Quantity: 100 [iU] in 1 mL
Code: GFX7QIS1II
Classification: ACTIB
Protamine sulfateInactive
Quantity: 0.28 mg in 1 mL
Code: 0DE9724IHC
Classification: IACT
GlycerinInactive
Quantity: 16 mg in 1 mL
Code: PDC6A3C0OX
Classification: IACT
ZincInactive
Quantity: .025 mg in 1 mL
Code: J41CSQ7QDS
Classification: IACT
MetacresolInactive
Quantity: 1.76 mg in 1 mL
Code: GGO4Y809LO
Classification: IACT
PhenolInactive
Quantity: .715 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT