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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

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histamine positive - FDA Drug Approval Details