carboprost tromethamine
Carboprost Tromethamine Injection, USP 250 mcg/mL (1 mL) Rx Only
Approved
Approval ID
5902edd8-16b3-4f52-ac35-b0f4dfb5ab6a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2023
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
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 Code68083-584
Application NumberANDA217657
Product Classification
M
Marketing Category
C73584
G
Generic Name
carboprost tromethamine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateAugust 8, 2023
FDA Product Classification
INGREDIENTS (6)
BENZYL ALCOHOLInactive
Quantity: 9.45 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
CARBOPROST TROMETHAMINEActive
Quantity: 250 ug in 1 mL
Code: U4526F86FJ
Classification: ACTIM
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
TROMETHAMINEInactive
Quantity: 83 ug in 1 mL
Code: 023C2WHX2V
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT