NDC 63323-229-01 - Protamine Sulfate

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
63323-229
Requested NDC
63323-229-01
Package NDCs from labels
63323-229-01, 63323-229-05, 63323-229-30, 63323-229-21, 63323-229-15, 63323-229-35, 63323-229-26, 63323-229-41, 63323-229-94, 63323-229-95
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2025-02-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Protamine Sulfate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-02-05HUMAN PRESCRIPTION DRUG LABEL
Protamine Sulfate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-03-18HUMAN PRESCRIPTION DRUG LABEL
PROTAMINE SULFATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-22HUMAN PRESCRIPTION DRUG LABEL
Protamine Sulfate - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-01-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-229-01Protamine Sulfate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION56
63323-229-05Protamine Sulfate25 in 1 TRAYINJECTION, SOLUTION256
63323-229-30Protamine Sulfate1 in 1 BOXINJECTION, SOLUTION16
63323-229-30Protamine Sulfate25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION256
63323-229-41Protamine Sulfate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION55
63323-229-94Protamine Sulfate25 in 1 TRAYINJECTION, SOLUTION255
63323-229-95Protamine Sulfate1 in 1 BOXINJECTION, SOLUTION15
63323-229-95Protamine Sulfate25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION255
63323-229-15Protamine Sulfate25 in 1 TRAYINJECTION, SOLUTION254
63323-229-21Protamine Sulfate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION54
63323-229-26Protamine Sulfate10 in 1 TRAYINJECTION, SOLUTION104
63323-229-26Protamine Sulfate25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION254
63323-229-35Protamine Sulfate1 in 1 BOXINJECTION, SOLUTION14
63323-229-35Protamine Sulfate25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-229PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 4 package rows20250214_e1964129-33f4-4e4e-86e3-8e6a4e65bd83.zip
63323-229PROTAMINE SULFATE (PROTAMINE SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 4 package rows20240208_8df0a819-9e1a-44ce-97a6-3ea82c867d44.zip
63323-229PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 6 package rows20240402_7a31fc4c-579f-45cc-9559-39cfad9a57b3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-229-01ML - Milliliter63323-229b248cdf3-93bc-4a84-89e5-acea106e1a1212024-10-04
63323-229-05ML - Milliliter63323-229032fd5ba-1f3c-4e1d-81b9-3705c5841b0512013-02-13
63323-229-15ML - Milliliter63323-2292b208c91-45ce-470d-b2a9-437acb3c8b3412014-06-03
63323-229-21ML - Milliliter63323-22964344195-578b-4a40-87c9-ef9de67820bf12019-08-06
63323-229-30ML - Milliliter63323-2295ea5d8d6-1de7-4af5-8c1b-e0894a56e10212013-02-13
63323-229-35ML - Milliliter63323-22940a33f29-25b5-4fda-8cf5-4d72172bfde512014-06-03
63323-229-41ML - Milliliter63323-22967a8c4b7-7114-4679-865f-5d31482ba3f312019-10-07
63323-229-94ML - Milliliter63323-2299bb4f4fa-de32-40f2-84d9-2d9bb18aefa412014-07-02
63323-229-95ML - Milliliter63323-2292b1c90ae-0261-4707-93c4-ade581e8110912014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROTAMINE SULFATEACTIVE INGREDIENT0DE9724IHCPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
PROTAMINEACTIVE MOIETY72G3UY6T4NPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
PROTAMINE SULFATEACTIVE INGREDIENT0DE9724IHCPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PROTAMINE SULFATEACTIVE INGREDIENT0DE9724IHCPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PROTAMINEACTIVE MOIETY72G3UY6T4NPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
PROTAMINEACTIVE MOIETY72G3UY6T4NPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFPROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

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 4 of 56 · 1,110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsExact identifier
unii: 451W47IQ8X
BM BM68 DROPSARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53f9c99a-0f20-0358-e063-6394a90af4e02026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5448c76a-2ecb-9402-e063-6294a90a6ad72026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 ALCOHOLCALC 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 Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: 451W47IQ8X
Male SupportAGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALISDeseret Biologicals, Inc.29cefc89-3bb6-484e-84ab-116b5827a4c32026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINABM Private Limited540bf4ca-c217-1aa1-e063-6394a90ab6402026-06-12WarningsExact identifier
unii: O40UQP6WCF
BM BM68 DROPSARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5410ec88-8c65-3b26-e063-6294a90adf072026-06-12WarningsExact identifier
unii: 451W47IQ8X
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 BM98 DROPSACID SULPH, AMYL NITROSUM, AQUILEGIA, CIMICIFUGA, PULSATILLA, SANGUINARIA, SABINATotal Operations Management LLC DBA:Bestmade Natural Products Micro5411fb53-7bd2-d904-e063-6294a90a2c582026-06-12WarningsExact identifier
unii: O40UQP6WCF
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.ea12ca3b-19e0-4d4a-9514-4d28d214e1e72026-06-12WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC107af8bc-b6af-4b85-8c8a-ea757dcef1da2026-06-12Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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