FDA.reportPublic FDA data

NDC 63323-564-63 - 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
63323-564
Requested NDC
63323-564-63
Package NDCs from labels
63323-564-21, 63323-564-97, 63323-564-63, 63323-564-65
Manufacturer
Fresenius Kabi USA, LLC | Gland Pharma Limited
Effective date
2026-09-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Enoxaparin Sodium - Fresenius Kabi USA, LLC | Gland Pharma LimitedFresenius Kabi USA, LLC | Gland Pharma Limited2026-09-09HUMAN PRESCRIPTION DRUG LABEL
Enoxaparin Sodium - Cardinal Health 107, LLCCardinal Health 107, LLC2026-09-02HUMAN PRESCRIPTION DRUG LABEL
Enoxaparin Sodium - Fresenius Kabi USA, LLC | Gland Pharma LimitedFresenius Kabi USA, LLC | Gland Pharma Limited2026-04-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-564-21Enoxaparin Sodium1 in 1 BLISTER PACKINJECTION19
63323-564-21Enoxaparin Sodium0.4 mL in 1 SYRINGEINJECTION0.49
63323-564-97Enoxaparin Sodium10 in 1 CARTONINJECTION109
63323-564-63Enoxaparin Sodium0.4 mL in 1 SYRINGEINJECTION0.43
63323-564-63Enoxaparin Sodium1 in 1 BLISTER PACKINJECTION13
63323-564-65Enoxaparin Sodium10 in 1 CARTONINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-564ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 3 package rows20240731_a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e.zip
63323-564ENOXAPARIN SODIUM INJECTION [FRESENIUS KABI USA, LLC]2Current NDC, Legacy NDC, 3 package rows20230623_c3be543e-8aff-4311-bf77-e7a5a814ca6f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-564-21ML - Milliliter63323-5642b51f54c-2d5e-446f-ac61-0d5a45a3e27d12019-11-12
63323-564-63ML - Milliliter63323-5645c47fa37-fa02-4120-8e2e-57cc11b7decb12022-08-04
63323-564-65ML - Milliliter63323-56423636002-8409-4723-9177-50b4226812e212022-08-04
63323-564-97ML - Milliliter63323-5644ee38396-d6e4-442f-9734-703679a7787612019-11-12

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 10 · 189 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Enoxaparin SodiumENOXAPARIN SODIUMCardinal Health 107, LLC45a66675-b159-42b8-9f18-ff80f28e15032026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078990
ndc (package): 55154-9586-5
ndc (product): 55154-9586
rxcui: 854235
spl id: 9baf7028-e55e-42fd-a36b-1c0ddd4421e6
spl set id: 45a66675-b159-42b8-9f18-ff80f28e1503
unii: 8NZ41MIK1O
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Humalog KwikPenINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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