FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
0703-8540
11-digit product format
007038540
Labeler code
0703
Product ID
0703-8540_1da236a6-bfd3-4265-b659-244b8168abfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
ANDA076726
Marketing category
ANDA
Marketing start
2014-11-17
Marketing end
2023-10-31
Substance
ENOXAPARIN SODIUM
Active strength
40 mg/.4mL
Pharmacologic classes
Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33a7d2c8-f5cf-4d97-8510-92190c5e0f12Product name720240606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-8540-21ML - Milliliter0703-854004672181-65ca-4dee-a6da-6d5be22805fe12014-12-01
0703-8540-23ML - Milliliter0703-85402625578a-5929-47cf-bc7c-590c2758769112014-12-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSNff0b75fd-7319-4dfd-8710-7d85fe788cae4
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDff0b75fd-7319-4dfd-8710-7d85fe788cae4
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSYff0b75fd-7319-4dfd-8710-7d85fe788cae4
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSYff0b75fd-7319-4dfd-8710-7d85fe788cae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0703-8540-230070385402310 SYRINGE in 1 CARTON (0703-8540-23) > .4 mL in 1 SYRINGE (0703-8540-21) 10 syringe2014-11-170000-00-00NoNoCurrent