Lovenox

Product NDC
55154-4028
11-digit product format
551544028
Labeler code
55154
Product ID
55154-4028_ebd70650-9a1a-4922-859c-d14448c43c70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enoxaparin sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Cardinal Health 107, LLC
Application
NDA020164
Marketing category
NDA
Marketing start
1993-03-29
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020164-001LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1993-03-29
N020164-002LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-01-30
N020164-003LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-27
N020164-004LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-27
N020164-005LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS1998-03-27
N020164-006LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / SUBCUTANEOUSRLD2000-06-02
N020164-007LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD2000-06-02
N020164-008LOVENOX (PRESERVATIVE FREE)ENOXAPARIN SODIUM150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD2000-06-02
N020164-009LOVENOXENOXAPARIN SODIUM300MG/3ML (100MG/ML)INJECTABLE / INTRAVENOUS, SUBCUTANEOUSABRLD2003-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
N020164-001AP
N020164-002AP
N020164-003AP
N020164-004AP
N020164-005AP
N020164-007AP
N020164-008AP
N020164-009AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020164-001LOVENOX (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1993-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-002LOVENOX (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-003LOVENOX (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-004LOVENOX (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-005LOVENOX (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS1998-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-006LOVENOX (PRESERVATIVE FREE)90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / SUBCUTANEOUSRLD2000-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-007LOVENOX (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD2000-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-008LOVENOX (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD2000-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-009LOVENOX300MG/3ML (100MG/ML)INJECTABLE / INTRAVENOUS, SUBCUTANEOUSABRLD2003-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020164-001LOVENOX (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1993-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-002LOVENOX (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-003LOVENOX (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-004LOVENOX (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-005LOVENOX (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS1998-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-006LOVENOX (PRESERVATIVE FREE)90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / SUBCUTANEOUSRLD2000-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-007LOVENOX (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD2000-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-008LOVENOX (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD2000-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-009LOVENOX300MG/3ML (100MG/ML)INJECTABLE / INTRAVENOUS, SUBCUTANEOUSABRLD2003-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-001LOVENOX (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1993-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-002LOVENOX (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-003LOVENOX (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-004LOVENOX (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-005LOVENOX (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS1998-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-006LOVENOX (PRESERVATIVE FREE)90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / SUBCUTANEOUSRLD2000-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-007LOVENOX (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD2000-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-008LOVENOX (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD2000-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-009LOVENOX300MG/3ML (100MG/ML)INJECTABLE / INTRAVENOUS, SUBCUTANEOUSABRLD2003-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020164-001LOVENOX (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1993-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-002LOVENOX (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-003LOVENOX (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-004LOVENOX (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-005LOVENOX (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD, RS1998-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-006LOVENOX (PRESERVATIVE FREE)90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / SUBCUTANEOUSRLD2000-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-007LOVENOX (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD2000-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-008LOVENOX (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD2000-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-009LOVENOX300MG/3ML (100MG/ML)INJECTABLE / INTRAVENOUS, SUBCUTANEOUSABRLD2003-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-001LOVENOX (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1993-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-002LOVENOX (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-003LOVENOX (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-004LOVENOX (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAPRLD1998-03-27fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020164-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-005AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-007AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-008AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N020164-009AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020164-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-007AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-008AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020164-009AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-007AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-008AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020164-009AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020164-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-007AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-008AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020164-009AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-007AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-008AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020164-009AB1fd3edfee7708…

Additional Listing Data#

Finished product
Yes
Brand name base
Lovenox
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENOXAPARIN SODIUM40 mg/.4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8NZ41MIK1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854235Internal RxNorm lookup
854236Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d263380-4f44-4fd8-aa2a-e69702ab258fAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4028-5Lovenox0.4 mL in 1 SYRINGEINJECTION0.418
55154-4028-5Lovenox5 in 1 BAGINJECTION518

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
enoxaparin sodiumACTIVE INGREDIENT8NZ41MIK1OLOVENOX (ENOXAPARIN SODIUM) INJECTION [CARDINAL HEALTH]7
enoxaparinACTIVE MOIETYE47C0NF7LVLOVENOX (ENOXAPARIN SODIUM) INJECTION [CARDINAL HEALTH]7
waterINACTIVE INGREDIENT059QF0KO0RLOVENOX (ENOXAPARIN SODIUM) INJECTION [CARDINAL HEALTH]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4028LOVENOX (ENOXAPARIN SODIUM) INJECTION [CARDINAL HEALTH 107, LLC]15Current NDC, Legacy NDC, 2 package rows20250507_3d263380-4f44-4fd8-aa2a-e69702ab258f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LovenoxENOXAPARIN SODIUMSanofi-Aventis U.S. LLC5017a927-2a24-4f27-89f9-27c805bf7d592026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020164
application number: NDA020164
LovenoxENOXAPARIN SODIUMCardinal Health 107, LLC3d263380-4f44-4fd8-aa2a-e69702ab258f2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020164
application number: NDA020164
ndc (product): 55154-4028
LovenoxENOXAPARIN SODIUMSanofi-Aventis U.S. LLCde6fb917-a94a-41ea-9d7d-937d4080ffcd2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020164
application number: NDA020164
Enoxaparin sodiumENOXAPARIN SODIUMSanofi-Aventis U.S. LLC20635579-c92d-4f6c-a332-1096d51002f22026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020164
application number: NDA020164
Enoxaparin SodiumENOXAPARIN SODIUMFresenius Kabi USA, LLC21b095d1-5ade-43e9-9114-30fbfb2331c92026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020164
application number: NDA020164
Enoxaparin SodiumENOXAPARIN SODIUMFresenius Kabi USA, LLC066f27ec-352c-4051-ba29-248e292690db2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020164
application number: NDA020164

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN3d263380-4f44-4fd8-aa2a-e69702ab258f18
854236Lovenox 40 MG in 0.4 mL Prefilled SyringePSN3d263380-4f44-4fd8-aa2a-e69702ab258f18
8542360.4 ML enoxaparin sodium 100 MG/ML Prefilled Syringe [Lovenox]SBD3d263380-4f44-4fd8-aa2a-e69702ab258f18
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD3d263380-4f44-4fd8-aa2a-e69702ab258f18
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY3d263380-4f44-4fd8-aa2a-e69702ab258f18
8542360.4 ML ENX sodium 100 MG/ML Prefilled Syringe [Lovenox]SY3d263380-4f44-4fd8-aa2a-e69702ab258f18
8542360.4 ML Lovenox 100 MG/ML Prefilled SyringeSY3d263380-4f44-4fd8-aa2a-e69702ab258f18
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY3d263380-4f44-4fd8-aa2a-e69702ab258f18
854236Lovenox 40 MG per 0.4 ML Prefilled SyringeSY3d263380-4f44-4fd8-aa2a-e69702ab258f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4028-5551544028055 SYRINGE in 1 BAG (55154-4028-5) / .4 mL in 1 SYRINGE5 syringe1993-03-290000-00-00NoNoCurrent