Enoxaparin Sodium

Product NDC
55154-5443
11-digit product format
551545443
Labeler code
55154
Product ID
55154-5443_3f60f51c-5484-4341-9bad-d7756dc997b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Cardinal Health
Application
ANDA077857
Marketing category
ANDA
Marketing start
2010-07-23
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55154-5443DDiscontinued by firm2026-08-17
excluded packagepackage55154-544355154-5443-5DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55154-5443-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55154-5443-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55154-5443-52ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55154-5443-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55154-5443-5cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55154-5443-5cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55154-5443-5302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55154-5443-5ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55154-5443-50efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55154-5443-5ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55154-5443-5367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55154-5443-5557ba5c1ecfa…9c80585c8c6e…

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
A077857-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23
A077857-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23
A077857-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23
A077857-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23
A077857-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23
A077857-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23
A077857-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077857-001AP
A077857-002AP
A077857-003AP
A077857-004AP
A077857-005AP
A077857-006AP
A077857-007AP

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 06:07:402026-07A077857-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077857-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077857-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077857-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077857-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077857-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077857-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077857-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2010-07-23b8a1b40f171c…

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 06:07:402026-07A077857-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-005AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-006AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077857-007AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077857-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-006AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077857-007AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-006AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077857-007AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077857-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-006AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077857-007AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-006AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077857-007AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077857-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077857-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077857-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077857-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077857-005AP1b8a1b40f171c…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enoxaparin SodiumENOXAPARIN SODIUMCardinal Health 107, LLC5e7568a6-cf8a-4de2-86ba-b94c8ab4c8062026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077857
application number: ANDA077857
Enoxaparin SodiumENOXAPARIN SODIUMSandoz Inc38f60bd8-b518-4098-a808-b8f5a3ae6a3a2024-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077857
application number: ANDA077857