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 7 of 56 · 1,110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: 451W47IQ8X
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: 451W47IQ8X
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: 451W47IQ8X
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsExact identifier
unii: 451W47IQ8X
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.376093e7-e09e-4a57-3199-195e452518662026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Migraine and HeadacheIRIS VERSICOLOR ROOT AND SODIUM CHLORIDEForces of Nature0dd2f2e2-78e2-435e-b7b2-ca590953ff942026-04-01WarningsExact identifier
unii: 451W47IQ8X
IndustrioxBERBERIS VULGARIS, TARAXACUM OFFICINALE, AMMONIUM CARBONICUM, CAMPHORA, SPINACIA, SULPHURICUM ACIDUM, NUX VOMICA, ACETONE, BENZINUM, BUTYL METHACRYLATE, CALCAREA CARBONICA, LACHESIS MUTUS, METHYL ETHYL KETONE, NAPHTHALINUM, PLUMBUM METALLICUM, TRICHLOROETHYLENE, FORLMALINUM, MTBE (TERT-BUTYL METHYL ETHER), PETROLEUM, CARBONEUM CHLORATUMNutritional Specialties, Inc.d77a58f8-68c3-4772-b938-473b203a1d472026-04-01WarningsExact identifier
unii: O40UQP6WCF
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM MURIATICUM, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.f4e7e469-baaf-4c61-af44-80b0832eadf02026-03-31WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
unii: 451W47IQ8X
H-Allergy FormulaALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NATRUM MURIATICUM, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, WYETHIA HELENIOIDESHealing Natural Oils LLC4e586360-b3c4-1ce0-e063-6394a90ab6b82026-03-31WarningsExact identifier
unii: 451W47IQ8X
Acne HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMBioActive Nutritional, Inc.2ab4ff53-4274-40c7-b05c-44d918d809be2026-03-31WarningsExact identifier
unii: 451W47IQ8X
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.ad6a08ec-5eba-405b-8a07-79ac86ab3e7a2026-03-31WarningsExact identifier
unii: 451W47IQ8X
ANX HPARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUMBioActive Nutritional, Inc.96035891-aea3-4138-bb26-801ad819f6392026-03-30WarningsExact identifier
unii: 451W47IQ8X
Spleen LiquescenceQUERCUS ROBUR, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.d800456d-60f0-413d-b310-91b8b881f6b92026-03-30WarningsExact identifier
unii: 451W47IQ8X
DepressoforcePICRICUM ACIDUM, ARSENICUM ALBUM, AURUM METALLICUM, IGNATIA AMARA, NATRUM MURIATICUM, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.e6b98979-a38c-4f13-af03-f5ffa962b4fa2026-03-27WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.077a9171-283d-47b6-bddc-34c739f6d69d2026-03-27WarningsExact identifier
unii: 451W47IQ8X
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: 451W47IQ8X
Reflux AwayABIES NIGRA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICANaturalCare8a00a72f-60df-4477-b7b8-abb6355e34da2026-03-24WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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