Enoxaparin Sodium

Product NDC
0548-5635
11-digit product format
005485635
Labeler code
0548
Product ID
0548-5635_5bfd44d1-e5fd-46c6-b172-37af53fdd38e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Amphastar Pharmaceuticals, Inc.
Application
ANDA076684
Marketing category
ANDA
Marketing start
2011-09-19
Marketing end
0000-00-00
Substance
ENOXAPARIN SODIUM
Active strength
100 mg/mL
Pharmacologic classes
Heparin, Low-Molecular-Weight [CS],Low Molecular Weight Heparin [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0548-5635-002025-07-24C16284748780-1f386c649-c7b9-0266-e053-dadaa90a7c1aab8118dc-aca8-478b-8290-a468cbe36ae1
0548-5635-002023-01-30C16284748780-1f386c649-c7b9-0266-e053-dadaa90a7c1aab8118dc-aca8-478b-8290-a468cbe36ae1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0548-5635-00ML - Milliliter0548-56350c8ff19d-8fa8-40f7-a689-2a484e0e191612013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Enoxaparin sodiumACTIVE INGREDIENT8NZ41MIK1OENOXAPARIN SODIUM INJECTION [AMPHASTAR PHARMACEUTICALS, INC.]5
enoxaparinACTIVE MOIETYE47C0NF7LVENOXAPARIN SODIUM INJECTION [AMPHASTAR PHARMACEUTICALS, INC.]5
waterINACTIVE INGREDIENT059QF0KO0RENOXAPARIN SODIUM INJECTION [AMPHASTAR PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0548-5635ENOXAPARIN SODIUM INJECTION [AMPHASTAR PHARMACEUTICALS, INC.]8Legacy NDC20181204_ab8118dc-aca8-478b-8290-a468cbe36ae1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0548-5635-000054856350010 SYRINGE in 1 CARTON (0548-5635-00) > 1 mL in 1 SYRINGE10 syringe2011-09-190000-00-00NoNoCurrent