CARBOPROST TROMETHAMINE
Carboprost Tromethamine Injection, USP
Approved
Approval ID
42736d6a-0ab3-4c3c-897d-406aad5a49c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2023
Manufacturers
FDA
Caplin Steriles Limited
DUNS: 650744670
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
carboprost tromethamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65145-132
Application NumberANDA216882
Product Classification
M
Marketing Category
C73584
G
Generic Name
carboprost tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateFebruary 22, 2023
FDA Product Classification
INGREDIENTS (6)
CARBOPROST TROMETHAMINEActive
Quantity: 250 ug in 1 mL
Code: U4526F86FJ
Classification: ACTIM
TROMETHAMINEInactive
Quantity: 83 ug in 1 mL
Code: 023C2WHX2V
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9.45 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT