FDA.reportPublic FDA data

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 8 of 56 · 1,110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Worafy Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4da864dc-e10c-1db9-e063-6394a90a09842026-03-22WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
unii: 451W47IQ8X
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: 451W47IQ8X
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b812c9-fb0a-5ee0-e063-6294a90a03e12026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b88e7c-eca0-5540-e063-6294a90a1b182026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b8c3f4-e528-c69d-e063-6294a90a5a342026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b7eb13-39c3-6f0e-e063-6394a90a40112026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8bb9c-d30f-152f-e063-6394a90a52082026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8dcbd-9e6b-1edc-e063-6394a90aac732026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFBM Private Limited4d285396-9df8-86bc-e063-6294a90ad4de2026-03-16WarningsExact identifier
unii: 451W47IQ8X
HZ HPLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NITRICUM ACIDUM, RANUNCULUS BULBOSUS, RHUS TOX, SEPIA, THUJA OCCIDENTALISBioActive Nutritional, Inc.b662dea8-4eb5-4c80-a5ab-7d36887327732026-03-13WarningsExact identifier
unii: 451W47IQ8X
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: 451W47IQ8X
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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