FDA.reportPublic FDA data

Enoxaparin Sodium

Product NDC
68001-637
11-digit product format
680010637
Labeler code
68001
Product ID
68001-637_3ff02fbe-5a9d-e284-e063-6294a90a0ef8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Enoxaparin Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
BluePoint Laboratories
Application
ANDA206834
Marketing category
ANDA
Marketing start
2025-04-14
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
2026-12-31
Current FDA listing
Yes

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206834-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29a50c72e98297…
2026-08-01 22:54:322026-06A206834-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29a50c72e98297…
2026-08-01 22:54:322026-06A206834-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29a50c72e98297…
2026-08-01 22:54:322026-06A206834-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29a50c72e98297…
2026-08-01 22:54:322026-06A206834-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29a50c72e98297…
2026-08-01 22:54:322026-06A206834-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29a50c72e98297…
2026-08-01 22:54:322026-06A206834-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2019-11-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206834-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A206834-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A206834-003AP1a50c72e98297…
2026-08-01 22:54:322026-06A206834-004AP1a50c72e98297…
2026-08-01 22:54:322026-06A206834-005AP1a50c72e98297…
2026-08-01 22:54:322026-06A206834-006AP1a50c72e98297…
2026-08-01 22:54:322026-06A206834-007AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 68001-637
Enoxaparin SodiumENOXAPARIN SODIUMNorthStar Rx LLC32f8d292-0dda-4931-81ea-ba47e23edf612024-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206834
application number: ANDA206834

Additional Listing Data#

Finished product
Yes
Brand name base
Enoxaparin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENOXAPARIN SODIUM100 mg/mL

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 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
854228Internal RxNorm lookup
854235Internal RxNorm lookup
854238Internal RxNorm lookup
854241Internal RxNorm lookup
854245Internal RxNorm lookup
854248Internal RxNorm lookup
854252Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2a8615b-a27e-4ab2-ae4c-592bbf4643c0Available 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
68001-637-42Enoxaparin Sodium10 in 1 CARTONINJECTION103
68001-637-43Enoxaparin Sodium1 mL in 1 SYRINGEINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-637-42ML - Milliliter68001-637802c535c-289b-4b3a-9757-67706eef693512025-01-14
68001-637-43ML - Milliliter68001-637abd329b7-35bd-4ec7-982b-939b8580969612025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-637ENOXAPARIN SODIUM INJECTION [BLUEPOINT LABORATORIES]2Current NDC, 2 package rows20250528_a2a8615b-a27e-4ab2-ae4c-592bbf4643c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSNa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSNa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSNa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSNa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSNa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSNa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSNa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCDa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCDa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSYa2a8615b-a27e-4ab2-ae4c-592bbf4643c03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-637-426800106374210 SYRINGE in 1 CARTON (68001-637-42) / 1 mL in 1 SYRINGE (68001-637-43) 10 syringe2025-04-14NoNoCurrent
68001-637-43680010637431 mL in 1 SYRINGE1 mlHistorical