histamine positive
Histamine Phosphate
Approved
Approval ID
1159c24c-d9ce-49a2-b0bd-dc27c710f146
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 28, 2020
Manufacturers
FDA
ALK-Abello, Inc.
DUNS: 809998847
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
histamine phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0268-0248
Application NumberBLA103754
Product Classification
M
Marketing Category
C73585
G
Generic Name
histamine phosphate
Product Specifications
Route of AdministrationINTRADERMAL
Effective DateAugust 25, 2020
FDA Product Classification
INGREDIENTS (4)
PHENOLInactive
Quantity: 0.004 mL in 1 mL
Code: 339NCG44TV
Classification: IACT
HISTAMINE PHOSPHATEActive
Quantity: 0.275 mg in 1 mL
Code: QWB37T4WZZ
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
histamine phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0268-0247
Application NumberBLA103754
Product Classification
M
Marketing Category
C73585
G
Generic Name
histamine phosphate
Product Specifications
Route of AdministrationPERCUTANEOUS
Effective DateAugust 25, 2020
FDA Product Classification
INGREDIENTS (5)
HISTAMINE PHOSPHATEActive
Quantity: 2.75 mg in 1 mL
Code: QWB37T4WZZ
Classification: ACTIM
PHENOLInactive
Quantity: 0.004 mL in 1 mL
Code: 339NCG44TV
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Quantity: 0.5 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT