carboprost tromethamine
Carboprost tromethamine injection, USP
Approved
Approval ID
32cb34f5-e199-4cf8-a848-aaec7d42bd10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2023
Manufacturers
FDA
SOLA Pharmaceuticals, LLC
DUNS: 080121345
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
NDC Product Code70512-859
Application NumberANDA216824
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 25, 2023
Generic Namecarboprost tromethamine
INGREDIENTS (6)
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
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CARBOPROST TROMETHAMINEActive
Quantity: 250 ug in 1 mL
Code: U4526F86FJ
Classification: ACTIM
TROMETHAMINEInactive
Quantity: 83 ug in 1 mL
Code: 023C2WHX2V
Classification: IACT