FDA.reportPublic FDA data

NDC 63323-605-01 - Enoxaparin Sodium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63323-605
Requested NDC
63323-605-01
Package NDCs from labels
63323-605-01, 63323-605-84, 63323-605-04, 63323-605-94
Manufacturer
Fresenius Kabi USA, LLC | Sanofi-Aventis Singapore Pte. Ltd. | Sanofi Winthrop Industrie | Sanofi-Aventis Deutschland GmbH | Patheon Manufacturing Services LLC
Effective date
2026-02-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Enoxaparin SodiumFresenius Kabi USA, LLC | Sanofi-Aventis Singapore Pte. Ltd. | Sanofi Winthrop Industrie | Sanofi-Aventis Deutschland GmbH | Patheon Manufacturing Services LLC2026-02-04HUMAN PRESCRIPTION DRUG LABEL
Enoxaparin SodiumFresenius Kabi USA, LLC | Sanofi-Aventis Singapore Pte. Ltd. | Sanofi Winthrop Industrie | Sanofi-Aventis Deutschland GmbH | Patheon Manufacturing Services LLC2026-02-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-605-01Enoxaparin Sodium1 in 1 CELLO PACKINJECTION19
63323-605-01Enoxaparin Sodium1 mL in 1 SYRINGEINJECTION19
63323-605-84Enoxaparin Sodium10 in 1 CARTONINJECTION109
63323-605-04Enoxaparin Sodium1 in 1 CELLO PACKINJECTION17
63323-605-04Enoxaparin Sodium1 mL in 1 SYRINGEINJECTION17
63323-605-94Enoxaparin Sodium10 in 1 CARTONINJECTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-605ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 3 package rows20230105_21b095d1-5ade-43e9-9114-30fbfb2331c9.zip
63323-605ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 3 package rows20220125_066f27ec-352c-4051-ba29-248e292690db.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-605-01ML - Milliliter63323-605fc9d2f19-2192-478a-8253-ae8665fd8ff212019-11-12
63323-605-04ML - Milliliter63323-6057e8e1b95-4268-45c7-bea4-4e27db97964612019-12-10
63323-605-84ML - Milliliter63323-6052cd48ec9-fc00-4322-8e78-9bbcb4b3d2bc12019-11-12
63323-605-94ML - Milliliter63323-605644a8fe6-7f93-4f17-a07c-2d31da85d9bc12019-12-10

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 5 of 11 · 211 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Enoxaparin SodiumENOXAPARIN SODIUMBluePoint Laboratoriesd978e06e-b758-460b-81d3-69f7a5b89b002025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854255
unii: 8NZ41MIK1O
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Enoxaparin SodiumENOXAPARIN SODIUMBluePoint Laboratoriesa2a8615b-a27e-4ab2-ae4c-592bbf4643c02025-09-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 854245
rxcui: 854248
rxcui: 854241
rxcui: 854252
rxcui: 854238
rxcui: 854228
rxcui: 854235
unii: 8NZ41MIK1O
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.