Enoxaparin Sodium

Product NDC
55154-9586
11-digit product format
551549586
Labeler code
55154
Product ID
55154-9586_bc15f03c-6537-4314-96e2-af7d56d9633d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA078990
Marketing category
ANDA
Marketing start
2024-07-16
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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078990-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28
A078990-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28
A078990-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28
A078990-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28
A078990-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28
A078990-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28
A078990-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
A078990-001AP
A078990-002AP
A078990-003AP
A078990-004AP
A078990-005AP
A078990-006AP
A078990-007AP

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 8 · 294 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078990-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078990-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078990-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078990-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078990-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078990-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078990-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078990-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2018-09-28b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078990-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-005AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-006AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A078990-007AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078990-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-006AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078990-007AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-006AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078990-007AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078990-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-006AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078990-007AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-006AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078990-007AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078990-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078990-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078990-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078990-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078990-005AP1b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
Enoxaparin Sodium
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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
45a66675-b159-42b8-9f18-ff80f28e1503Available 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
55154-9586-5Enoxaparin Sodium5 in 1 BAGINJECTION55
55154-9586-5Enoxaparin Sodium0.4 mL in 1 SYRINGEINJECTION0.45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9586ENOXAPARIN SODIUM INJECTION [CARDINAL HEALTH 107, LLC]1Current NDC, 2 package rows20240718_45a66675-b159-42b8-9f18-ff80f28e1503.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
Enoxaparin SodiumENOXAPARIN SODIUMCardinal Health 107, LLC45a66675-b159-42b8-9f18-ff80f28e15032026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078990
application number: ANDA078990
ndc (product): 55154-9586
Enoxaparin SodiumENOXAPARIN SODIUMFresenius Kabi USA, LLCc3be543e-8aff-4311-bf77-e7a5a814ca6f2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078990
application number: ANDA078990
ENOXAPARIN SODIUMENOXAPARIN SODIUMGland Pharma Limited65025e0d-eb54-4c4e-bd14-f294ce0389022026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078990
application number: ANDA078990
Enoxaparin SodiumENOXAPARIN SODIUMCivica, Inc.b4728749-8453-4f07-9fbc-a1f3e9d2708b2025-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078990
application number: ANDA078990
Enoxaparin SodiumENOXAPARIN SODIUMFresenius Kabi USA, LLCa694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e2025-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078990
application number: ANDA078990
Enoxaparin SodiumENOXAPARIN SODIUMSagent Pharmaceuticals419a3566-4f67-4c8d-86e5-c00c7ec429e12023-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078990
application number: ANDA078990

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN45a66675-b159-42b8-9f18-ff80f28e15035
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD45a66675-b159-42b8-9f18-ff80f28e15035
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY45a66675-b159-42b8-9f18-ff80f28e15035
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY45a66675-b159-42b8-9f18-ff80f28e15035

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-9586-5551549586055 SYRINGE in 1 BAG (55154-9586-5) / .4 mL in 1 SYRINGE5 syringe2024-07-16NoNoCurrent