Enoxaparin Sodium

Product NDC
71288-411
11-digit product format
712880411
Labeler code
71288
Product ID
71288-411_7b3fe31e-ec77-4ae9-bdf2-e3e410b005bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA206834
Marketing category
ANDA
Marketing start
2019-12-01
Marketing end
0000-00-00
Substance
ENOXAPARIN SODIUM
Active strength
150 mg/mL
Pharmacologic classes
Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71288-411DDiscontinued by firm2026-08-03
excluded packagepackage71288-41171288-411-81DDiscontinued by firm2026-08-03
excluded packagepackage71288-41171288-411-83DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A206834-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29
A206834-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29
A206834-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29
A206834-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29
A206834-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29
A206834-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29
A206834-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206834-001AP
A206834-002AP
A206834-003AP
A206834-004AP
A206834-005AP
A206834-006AP
A206834-007AP

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 7 · 266 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206834-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206834-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206834-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206834-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206834-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206834-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206834-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-2903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 266 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206834-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-006AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206834-007AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-006AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206834-007AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206834-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-006AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206834-007AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-005AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-006AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206834-007AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-005AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-006AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206834-007AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206834-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206834-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206834-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206834-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206834-005AP103ed91905a0d…

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
71288-411-80ML - Milliliter71288-411f17c035c-4203-4821-b61e-fbb7dca771a012020-05-08
71288-411-81ML - Milliliter71288-411332fd3de-3d06-44f9-8d82-7f405012036d12020-05-08
71288-411-82ML - Milliliter71288-411d82419cd-9cfd-4b93-a475-cf18149deb2612020-05-08
71288-411-83ML - Milliliter71288-411c3d2bc28-1c2c-4d38-b74f-fa3321d1de3a12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-411ENOXAPARIN SODIUM INJECTION [MEITHEAL PHARMACEUTICALS INC.]5Legacy NDC20221220_d42b7d26-6e72-4609-b95d-5b1bf280b9ed.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enoxaparin SodiumENOXAPARIN SODIUMMeitheal Pharmaceuticals Inc.b6fb85ab-1fe5-4dd3-a97f-adbed0674f672026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206834
application number: ANDA206834
Enoxaparin SodiumENOXAPARIN SODIUMMeitheal Pharmaceuticals Inc.adbba7bb-fa72-4cec-aa69-13965591a45d2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206834
application number: ANDA206834
Enoxaparin SodiumENOXAPARIN SODIUMBluePoint Laboratoriesa2a8615b-a27e-4ab2-ae4c-592bbf4643c02025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206834
application number: ANDA206834
Enoxaparin SodiumENOXAPARIN SODIUMNorthStar Rx LLC32f8d292-0dda-4931-81ea-ba47e23edf612024-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206834
application number: ANDA206834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-411-817128804118110 SYRINGE in 1 CARTON (71288-411-81) > .8 mL in 1 SYRINGE (71288-411-80) 10 syringe2019-12-010000-00-00NoNoCurrent
71288-411-837128804118310 SYRINGE in 1 CARTON (71288-411-83) > 1 mL in 1 SYRINGE (71288-411-82) 10 syringe2019-12-010000-00-00NoNoCurrent