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United States · US · US:63323-535_a12d41f8-475d-4932-9aa0-73180eb1fd60
Enoxaparin Sodium
Orange BookUNIISPLATC B01AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeB01AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633235359810 CELLO PACK in 1 CARTON (63323-535-98) / 1 SYRINGE in 1 CELLO PACK (63323-535-08) / .4 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
8NZ41MIK1O
ENOXAPARIN SODIUM
RxCUI 221095
Orange Book
N020164
APAPAPAPAPAPAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8NZ41MIK1O",
"rxcui": "221095",
"inchikey": null,
"display_name": "ENOXAPARIN SODIUM",
"substance_type": "polymer",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"5e7568a6-cf8a-4de2-86ba-b94c8ab4c806": {
"match": "brand_token",
"title": "ENOXAPARIN SODIUM INJECTION [CARDINAL HEALTH 107, LLC]",
"spl_version": "7",
"published_date": "2026-05-13"
}
},
"productid": "63323-535_a12d41f8-475d-4932-9aa0-73180eb1fd60",
"productndc": "63323-535",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "020164",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "30MG/0.3ML (100MG/ML)",
"product_no": "001",
"approval_date": "Mar 29, 1993"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "40MG/0.4ML (100MG/ML)",
"product_no": "002",
"approval_date": "Jan 30, 1998"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "60MG/0.6ML (100MG/ML)",
"product_no": "003",
"approval_date": "Mar 27, 1998"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "80MG/0.8ML (100MG/ML)",
"product_no": "004",
"approval_date": "Mar 27, 1998"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "100MG/ML (100MG/ML)",
"product_no": "005",
"approval_date": "Mar 27, 1998"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "006",
"approval_date": "Jun 2, 2000"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "120MG/0.8ML (150MG/ML)",
"product_no": "007",
"approval_date": "Jun 2, 2000"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "150MG/ML (150MG/ML)",
"product_no": "008",
"approval_date": "Jun 2, 2000"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "300MG/3ML (100MG/ML)",
"product_no": "009",
"approval_date": "Jan 23, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENOXAPARIN SODIUM",
"proprietary_name": "Enoxaparin Sodium",
"active_ingred_unit": "mg/.4mL",
"application_number": "NDA020164",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "enoxaparin sodium",
"start_marketing_date": "20190618",
"active_numerator_strength": "40"
}Related drugs
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- GBArovi 40mg/0.4ml solution for injection pre-filled syringesROVI Biotech Ltd
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- GBArovi 80mg/0.8ml solution for injection pre-filled syringesROVI Biotech Ltd
- CAAXBERIBAXTER CORPORATION
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