Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Chemicals Private Limited
Hospira, Inc.
862603148
GLAND PHARMA LIMITED
Hospira, Inc.
858971074
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rocuronium bromide
Product Details
NDC Product Code
0409-1403Application Number
ANDA205656Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
August 29, 2023SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
RocuroniumActive
Code: I65MW4OFHZClass: ACTIBQuantity: 10 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 3.10 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
rocuronium bromide
Product Details
NDC Product Code
0409-5160Application Number
ANDA205656Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
August 29, 2023RocuroniumActive
Code: I65MW4OFHZClass: ACTIBQuantity: 10 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 3.10 mg in 1 mL