Sodium Ferric Gluconate Complex in Sucrose

Product NDC

0591-2508

11-digit product format

005912508

Labeler code

0591

Product ID

0591-2508_7f8cad1c-04ec-4ca7-bf25-f0e2da50a03b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Sodium Ferric Gluconate Complex

Dosage form

INJECTION

Route

INTRAVENOUS

Labeler

Actavis Pharma, Inc.

Application

ANDA078215

Marketing category

ANDA

Marketing start

2012-08-23

Marketing end

2019-06-30

Substance

SODIUM FERRIC GLUCONATE COMPLEX

Active strength

13 mg/mL

Pharmacologic classes

Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record