Enoxaparin Sodium

Product NDC
0703-8530
Requested package NDC
0703-8530-23
11-digit product format
007038530
Labeler code
0703
Product ID
0703-8530_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
2014-12-19
Marketing end
2023-09-30
Substance
ENOXAPARIN SODIUM
Active strength
30 mg/.3mL
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0703-85300703-8530-23DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
A076726-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23
A076726-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23
A076726-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23
A076726-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23
A076726-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23
A076726-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23
A076726-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076726-001AP
A076726-002AP
A076726-003AP
A076726-004AP
A076726-005AP
A076726-006AP
A076726-007AP

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 06:07:402026-07A076726-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076726-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076726-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076726-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076726-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076726-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076726-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076726-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2014-06-23b8a1b40f171c…

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 06:07:402026-07A076726-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-005AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-006AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A076726-007AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076726-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-006AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076726-007AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-006AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076726-007AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076726-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-006AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076726-007AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-006AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076726-007AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076726-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076726-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076726-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076726-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076726-005AP1b8a1b40f171c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-8530-21ML - Milliliter0703-85309a3669f7-7022-4f59-99d8-ac70402f597812014-12-01
0703-8530-23ML - Milliliter0703-8530d3717523-ba5b-4e3f-9cb8-ea30a123fd6b12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENOXAPARIN SODIUMACTIVE INGREDIENT8NZ41MIK1OENOXAPARIN SODIUM INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]1
ENOXAPARINACTIVE MOIETYE47C0NF7LVENOXAPARIN SODIUM INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RENOXAPARIN SODIUM INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]1

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 SODIUMZydus Pharmaceuticals USA Inc.d8afb29f-cbed-43bc-809f-09b30fca28f52024-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076726
application number: ANDA076726
Enoxaparin SodiumENOXAPARIN SODIUMItalfarmaco SpAb4d9e4d4-4fdb-48d6-a169-7bc5eebc51e92022-11-05Exact identifier
application applno (ANDA): 076726
application number: ANDA076726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0703-8530-230070385302310 SYRINGE in 1 CARTON (0703-8530-23) > .3 mL in 1 SYRINGE (0703-8530-21) 10 syringe2014-12-192023-09-30NoNoCurrent