Positive Skin Test Control - Histamine
Histamine 366140-H05 Initial Upload to Intagras SPL Portal
Approved
Approval ID
5c20f3f4-65f8-4cdb-bdd1-5774da1c551b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Jubilant HollisterStier LLC
DUNS: 069263643
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Histamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65044-9998
Application NumberBLA103891
Product Classification
M
Marketing Category
C73585
G
Generic Name
Histamine
Product Specifications
Route of AdministrationPERCUTANEOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (4)
HISTAMINEActive
Quantity: 6 mg in 1 mL
Code: 820484N8I3
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT