Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Caplin Steriles Limited
650744670
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Caplin Steriles Limited
NorthStar Rx LLC
Caplin Steriles Limited
650744670
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NOREPINEPHRINE BITARTRATE
Product Details
NDC Product Code
72603-180Application Number
ANDA217575Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 1, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
NorepinephrineActive
Code: IFY5PE3ZRWClass: ACTIMQuantity: 1 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT