FDA.reportPublic FDA data

NDC 63323-047-01 - Heparin 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
63323-047
Requested NDC
63323-047-01
Package NDCs from labels
63323-047-01, 63323-047-10
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2025-11-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Heparin Sodium - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-11-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-047-01Heparin Sodium10 mL in 1 VIALINJECTION, SOLUTION1013
63323-047-10Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-047HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]12Current NDC, Legacy NDC, 2 package rows20241017_d55b4a63-0c04-4874-b74f-9e9b9e8b008c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-047-01ML - Milliliter63323-0473c7fe6df-fb98-4356-bce7-00d4fbdd307f12022-03-09
63323-047-10ML - Milliliter63323-0472b4385e4-7fbb-450e-9620-6748a96f842e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9

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 15 of 50 · 987 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: 451W47IQ8X
BM Nat MurNATRIUM MURIATICUMBM Private Limited37b12318-dff9-e32a-e063-6394a90a18e82025-12-02WarningsExact identifier
unii: 451W47IQ8X
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARBM Private Limited37c27f80-7689-c5a1-e063-6294a90a619b2025-12-02WarningsExact identifier
unii: 451W47IQ8X
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist MeijerSODIUM CHLORIDEMeijer, Inc.445c8f4f-0519-0764-e063-6294a90a8b392025-12-01WarningsExact identifier
unii: 451W47IQ8X
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLCd55b4a63-0c04-4874-b74f-9e9b9e8b008c2025-11-28Warnings, Adverse reactionsExact identifier
application number: NDA017651
application number: NDA017029
ndc (package): 63323-459-09
ndc (package): 63323-047-01
ndc (package): 63323-542-01
ndc (package): 63323-276-01
ndc (package): 63323-276-02
ndc (package): 63323-262-01
ndc (package): 63323-540-31
ndc (package): 63323-915-01
ndc (package): 63323-542-07
ndc (package): 63323-047-10
ndc (package): 63323-540-01
ndc (package): 63323-543-02
ndc (package): 63323-540-11
ndc (product): 63323-542
ndc (product): 63323-459
ndc (product): 63323-540
ndc (product): 63323-047
ndc (product): 63323-276
ndc (product): 63323-543
ndc (product): 63323-915
ndc (product): 63323-262
ndc11 (package): 63323004701
rxcui: 1361226
rxcui: 1658634
rxcui: 1362831
rxcui: 1361615
rxcui: 1361574
rxcui: 1658647
spl id: 529104c9-6154-4428-953d-5546875f32e5
spl set id: d55b4a63-0c04-4874-b74f-9e9b9e8b008c
unii: ZZ45AB24CA
Heparin SodiumHEPARIN SODIUMFresenius Kabi USA, LLCed937dd2-8fab-4875-a1e8-627b71ccb7fb2025-11-27Warnings, Adverse reactionsExact identifier
application number: NDA017029
ndc (product): 63323-540
ndc (product): 63323-262
rxcui: 1361226
rxcui: 1361615
spl id: df982e37-d056-462a-9df5-2105e16504d2
spl set id: ed937dd2-8fab-4875-a1e8-627b71ccb7fb
unii: ZZ45AB24CA
Walgreen SalineNASALWALGREENS CO.ee264d8b-0bb2-472a-907c-6a6291f154cd2025-11-26WarningsExact identifier
unii: 451W47IQ8X
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
unii: LKG8494WBH
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: 451W47IQ8X
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
unii: 451W47IQ8X
Heparin SodiumHEPARIN SODIUMSagent Pharmaceticalsef309d83-7262-4874-8580-f4ca254f963a2025-11-18Warnings, Adverse reactionsExact identifier
rxcui: 1361226
rxcui: 1362831
rxcui: 1361615
unii: ZZ45AB24CA
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCce0c8c6f-734a-400f-9b60-a3b1e263f25f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Heparin SodiumHEPARIN SODIUMSagent Pharmaceuticals6d5eae7d-a5f6-411c-b589-3e5f7eecc8752025-11-18Warnings, Adverse reactionsExact identifier
rxcui: 1658647
unii: ZZ45AB24CA
Heparin SodiumHEPARIN SODIUMSagent Pharmaceuticalsfeec2820-502f-4a97-84c9-f173729c51d32025-11-18Warnings, Adverse reactionsExact identifier
rxcui: 1361574
unii: ZZ45AB24CA
Heparin SodiumHEPARIN SODIUMSagent Pharmaceuticals8ebe4b4d-cb28-47e8-9598-6105d250b3d22025-11-18Warnings, Adverse reactionsExact identifier
rxcui: 1361226
rxcui: 1362831
rxcui: 1361615
unii: ZZ45AB24CA

Reported adverse events (FAERS/openFDA)#

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