carboprost tromethamine
Carboprost Tromethamine Injection, USP [250 mcg/mL (1 mL)] Rx Only
Approved
Approval ID
eac3fd1c-ca4b-4aa3-9dc2-e7dbeb4c122a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 23, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
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 Code70121-1680
Application NumberANDA215337
Product Classification
M
Marketing Category
C73584
G
Generic Name
carboprost tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 23, 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