Fondaparinux Sodium

Product NDC
43598-607
11-digit product format
435980607
Labeler code
43598
Product ID
43598-607_a0391e02-8a69-6aa6-d687-f740a2a44bfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fondaparinux Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA091316
Marketing category
ANDA
Marketing start
2017-07-27
Marketing end
0000-00-00
Substance
FONDAPARINUX SODIUM
Active strength
3 mg/.5mL
Pharmacologic classes
Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-607-02ML - Milliliter43598-607dd1c14d7-d1bf-4869-b31d-5cc67c97d4cb12017-09-11
43598-607-10ML - Milliliter43598-6079a77e084-01d8-4472-904c-557fcca68de712017-09-11
43598-607-11ML - Milliliter43598-60757a428bf-e0a5-4d2a-86de-b00f1bb11f6712019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-607FONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES INC.]5Legacy NDC20221224_8a27f341-f612-de72-8c1f-3fd977905de0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-607-02435980607022 SYRINGE in 1 CARTON (43598-607-02) > .5 mL in 1 SYRINGE (43598-607-11) 2 syringe2017-07-270000-00-00NoNoCurrent
43598-607-104359806071010 SYRINGE in 1 CARTON (43598-607-10) > .5 mL in 1 SYRINGE (43598-607-11) 10 syringe2017-07-270000-00-00NoNoCurrent