Fondaparinux Sodium

Product NDC
43598-608
11-digit product format
435980608
Labeler code
43598
Product ID
43598-608_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
5 mg/.4mL
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
43598-608-02ML - Milliliter43598-60836b25206-b7a2-4951-986b-6f4cbe1c5a9e12017-09-11
43598-608-10ML - Milliliter43598-60869712bdd-f3df-497a-ae4b-ab51a2b4232612017-09-11
43598-608-11ML - Milliliter43598-6085f60c457-4815-45ae-8ffd-3e9032b4d8aa12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-608FONDAPARINUX 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
43598-608-02435980608022 SYRINGE in 1 CARTON (43598-608-02) > .4 mL in 1 SYRINGE (43598-608-11) 2 syringe2017-07-270000-00-00NoNoCurrent
43598-608-104359806081010 SYRINGE in 1 CARTON (43598-608-10) > .4 mL in 1 SYRINGE (43598-608-11) 10 syringe2017-07-270000-00-00NoNoCurrent