Pamidronate Disodium
Pamidronate Disodium Injection
Approved
Approval ID
9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PAMIDRONATE DISODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61703-326
Application NumberANDA075841
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAMIDRONATE DISODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (5)
MANNITOLInactive
Quantity: 37.5 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
PAMIDRONATE DISODIUMActive
Quantity: 9 mg in 1 mL
Code: 8742T8ZQZA
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PAMIDRONATE DISODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61703-324
Application NumberANDA075841
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAMIDRONATE DISODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (5)
PAMIDRONATE DISODIUMActive
Quantity: 3 mg in 1 mL
Code: 8742T8ZQZA
Classification: ACTIB
MANNITOLInactive
Quantity: 47 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PAMIDRONATE DISODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61703-325
Application NumberANDA075841
Product Classification
M
Marketing Category
C73584
G
Generic Name
PAMIDRONATE DISODIUM
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (5)
MANNITOLInactive
Quantity: 40 mg in 1 mL
Code: 3OWL53L36A
Classification: IACT
PAMIDRONATE DISODIUMActive
Quantity: 6 mg in 1 mL
Code: 8742T8ZQZA
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT