Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rebel Distributors Corp
Rebel Distributors Corp
118802834
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sterile Vancomycin Hydrochloride
Product Details
NDC Product Code
21695-424Application Number
ANDA065397Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
August 18, 2010VancomycinActive
Code: 71WO621TJDClass: ACTIMQuantity: 500 mg in 10 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT