Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Caplin Steriles Limited
Caplin Steriles Limited
650744670
Products1
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 Code
65145-132Application Number
ANDA216882Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
February 22, 2023Carboprost tromethamineActive
Code: U4526F86FJClass: ACTIMQuantity: 250 ug in 1 mL
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 83 ug in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT