Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Pharma Limited
Gland Pharma Limited
858971074
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
68083-584Application Number
ANDA217657Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
August 8, 2023BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 mg in 1 mL
Carboprost tromethamineActive
Code: U4526F86FJClass: ACTIMQuantity: 250 ug in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 83 ug in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT