Pamidronate Disodium
Pamidronate Disodium Injection
Approved
Approval ID
c2ca033e-fa5f-4141-b702-11f8b4303da1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2023
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 2
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 Code67457-430
Application NumberANDA078520
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pamidronate Disodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2018
FDA Product Classification
INGREDIENTS (4)
PAMIDRONATE DISODIUMActive
Quantity: 3 mg in 1 mL
Code: 8742T8ZQZA
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Pamidronate Disodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-446
Application NumberANDA078520
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pamidronate Disodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2018
FDA Product Classification
INGREDIENTS (4)
PAMIDRONATE DISODIUMActive
Quantity: 9 mg in 1 mL
Code: 8742T8ZQZA
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT