FDA.reportPublic FDA data

enoxaparin sodium

Product NDC
28955-101
Requested package NDC
28955-101-10
11-digit product format
289550101
Labeler code
28955
Product ID
28955-101_486592e2-4eef-525e-e063-6394a90a3048
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
enoxaparin sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Hebei Changshan Biochemical Pharmaceutical Co., Ltd.
Application
ANDA218775
Marketing category
ANDA
Marketing start
2026-05-01
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
2027-12-31
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
A218775-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07
A218775-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07
A218775-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07
A218775-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07
A218775-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07
A218775-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07
A218775-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)ENOXAPARIN SODIUM150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218775-001AP
A218775-002AP
A218775-003AP
A218775-004AP
A218775-005AP
A218775-006AP
A218775-007AP

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
2026-02-19 14:30 UTC2026-02A218775-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-001ENOXAPARIN SODIUM (PRESERVATIVE FREE)30MG/0.3ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-002ENOXAPARIN SODIUM (PRESERVATIVE FREE)40MG/0.4ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-003ENOXAPARIN SODIUM (PRESERVATIVE FREE)60MG/0.6ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-004ENOXAPARIN SODIUM (PRESERVATIVE FREE)80MG/0.8ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-005ENOXAPARIN SODIUM (PRESERVATIVE FREE)100MG/ML (100MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-006ENOXAPARIN SODIUM (PRESERVATIVE FREE)120MG/0.8ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-007ENOXAPARIN SODIUM (PRESERVATIVE FREE)150MG/ML (150MG/ML)INJECTABLE / SUBCUTANEOUSAP2026-01-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218775-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-006AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218775-007AP1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-003AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-004AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-005AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-006AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218775-007AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
enoxaparin sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENOXAPARIN SODIUM30 mg/.3mL

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
7fa78f8d-92d9-434a-8e26-b886ab0ae77fAvailable 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
28955-101-10enoxaparin sodium10 in 1 CARTONINJECTION102
28955-101-10enoxaparin sodium0.3 mL in 1 SYRINGEINJECTION0.32

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
enoxaparin sodiumENOXAPARIN SODIUMHebei Changshan Biochemical Pharmaceutical Co., Ltd.7fa78f8d-92d9-434a-8e26-b886ab0ae77f2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218775
application number: ANDA218775
ndc (package): 28955-101-10
ndc (product): 28955-101
ndc11 (package): 28955010110

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854248enoxaparin sodium 100 MG in 1 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854245enoxaparin sodium 120 MG in 0.8 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854252enoxaparin sodium 150 MG in 1 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854228enoxaparin sodium 30 MG in 0.3 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854235enoxaparin sodium 40 MG in 0.4 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854238enoxaparin sodium 60 MG in 0.6 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854241enoxaparin sodium 80 MG in 0.8 ML Prefilled SyringePSN7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542280.3 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542350.4 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542380.6 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542410.8 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542450.8 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542481 ML enoxaparin sodium 100 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542521 ML enoxaparin sodium 150 MG/ML Prefilled SyringeSCD7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542280.3 ML ENX sodium 100 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542350.4 ML ENX sodium 100 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542380.6 ML ENX sodium 100 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542410.8 ML ENX sodium 100 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542450.8 ML ENX sodium 150 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542481 ML ENX sodium 100 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
8542521 ML ENX sodium 150 MG/ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854252enoxaparin 150 MG per 1 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854248enoxaparin sodium 100 MG per 1 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854245enoxaparin sodium 120 MG per 0.8 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854228enoxaparin sodium 30 MG per 0.3 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854235enoxaparin sodium 40 MG per 0.4 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854238enoxaparin sodium 60 MG per 0.6 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2
854241enoxaparin sodium 80 MG per 0.8 ML Prefilled SyringeSY7fa78f8d-92d9-434a-8e26-b886ab0ae77f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
28955-101-102895501011010 SYRINGE in 1 CARTON (28955-101-10) / .3 mL in 1 SYRINGE10 syringe2026-05-01NoNoCurrent