Hemabate
Hemabate carboprost tromethamine injection, USP
Approved
Approval ID
3d282998-ff0c-480a-bd80-155606ef0a65
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2022
Manufacturers
FDA
Pharmacia & Upjohn Company LLC
DUNS: 618054084
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 Code0009-0856
Application NumberNDA017989
Product Classification
M
Marketing Category
C73594
G
Generic Name
carboprost tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 10, 2022
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