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 | Type |
|---|---|---|---|
| Protamine Sulfate - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2025-02-05 | HUMAN PRESCRIPTION DRUG LABEL |
| Protamine Sulfate - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2024-03-18 | HUMAN PRESCRIPTION DRUG LABEL |
| PROTAMINE SULFATE - HF Acquisition Co LLC, DBA HealthFirst | HF Acquisition Co LLC, DBA HealthFirst | 2024-01-22 | HUMAN PRESCRIPTION DRUG LABEL |
| Protamine Sulfate - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2024-01-18 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-229-01 | Protamine Sulfate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 6 | |
| 63323-229-05 | Protamine Sulfate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 6 | |
| 63323-229-30 | Protamine Sulfate | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 6 | |
| 63323-229-30 | Protamine Sulfate | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | 6 | |
| 63323-229-41 | Protamine Sulfate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 5 | |
| 63323-229-94 | Protamine Sulfate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 5 | |
| 63323-229-95 | Protamine Sulfate | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 5 | |
| 63323-229-95 | Protamine Sulfate | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | 5 | |
| 63323-229-15 | Protamine Sulfate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 4 | |
| 63323-229-21 | Protamine Sulfate | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | 4 | |
| 63323-229-26 | Protamine Sulfate | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | 4 | |
| 63323-229-26 | Protamine Sulfate | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | 4 | |
| 63323-229-35 | Protamine Sulfate | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 4 | |
| 63323-229-35 | Protamine Sulfate | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-229 | PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250214_e1964129-33f4-4e4e-86e3-8e6a4e65bd83.zip |
| 63323-229 | PROTAMINE SULFATE (PROTAMINE SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240208_8df0a819-9e1a-44ce-97a6-3ea82c867d44.zip |
| 63323-229 | PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 6 package rows | 20240402_7a31fc4c-579f-45cc-9559-39cfad9a57b3.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-229-01 | ML - Milliliter | 63323-229 | b248cdf3-93bc-4a84-89e5-acea106e1a12 | 1 | 2024-10-04 |
| 63323-229-05 | ML - Milliliter | 63323-229 | 032fd5ba-1f3c-4e1d-81b9-3705c5841b05 | 1 | 2013-02-13 |
| 63323-229-15 | ML - Milliliter | 63323-229 | 2b208c91-45ce-470d-b2a9-437acb3c8b34 | 1 | 2014-06-03 |
| 63323-229-21 | ML - Milliliter | 63323-229 | 64344195-578b-4a40-87c9-ef9de67820bf | 1 | 2019-08-06 |
| 63323-229-30 | ML - Milliliter | 63323-229 | 5ea5d8d6-1de7-4af5-8c1b-e0894a56e102 | 1 | 2013-02-13 |
| 63323-229-35 | ML - Milliliter | 63323-229 | 40a33f29-25b5-4fda-8cf5-4d72172bfde5 | 1 | 2014-06-03 |
| 63323-229-41 | ML - Milliliter | 63323-229 | 67a8c4b7-7114-4679-865f-5d31482ba3f3 | 1 | 2019-10-07 |
| 63323-229-94 | ML - Milliliter | 63323-229 | 9bb4f4fa-de32-40f2-84d9-2d9bb18aefa4 | 1 | 2014-07-02 |
| 63323-229-95 | ML - Milliliter | 63323-229 | 2b1c90ae-0261-4707-93c4-ade581e81109 | 1 | 2014-07-02 |
DailyMed Socrata Ingredients#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Acne Relief | BELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHUR | NaturalCare | 487b1373-b78c-4510-964a-6ab0fe781ff4 | 2026-05-08 | Warnings | 451W47IQ8X |
| Migraine Relief | BELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS | The Magni Company | 79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d | 2026-05-07 | Warnings | 451W47IQ8X |
| Sterile Water | WATER | Hospira, Inc. | 3a6422e1-feee-4095-8883-2b0837039e6e | 2026-05-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Viril | BENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANA | Deseret Biologicals, Inc. | 3701cc0d-91ed-45fd-98b8-9d8cfba9c787 | 2026-05-06 | Warnings | 451W47IQ8X |
| Trauma plus Gel | CALENDULA OFFICINALIS, ARNICA MONTANA, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, BELLIS PERENNIS, LEDUM PALUSTRE, SULPHURICUM ACIDUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, RHUS TOX, RUTA GRAVEOLENS, NATRUM SULPHURICUM | Energique, Inc. | 53f4232b-23d4-48dc-aa76-175fdebfc74f | 2026-05-06 | Warnings | O40UQP6WCF |
| Multi Flower | AESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOS | Energique, Inc. | 09c059e7-f748-402c-8447-af5b61169c58 | 2026-05-06 | Warnings | 059QF0KO0R |
| Sodium Chloride | SODIUM CHLORIDE | Sportpharm LLC | a2c111f6-74d5-4a5d-82ac-d0f237488cb8 | 2026-04-24 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Method Pharmaceuticals, LLC | 4b08859e-65bd-8255-e063-6394a90af614 | 2026-04-23 | Warnings | 451W47IQ8X |
| Ringers | SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | ICU Medical, Inc. | a926f913-18fa-4a3e-bfd6-210e1e427960 | 2026-04-20 | Warnings, Adverse reactions | 451W47IQ8X |
| Cardioforce II | ABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNIS | BioActive Nutritional, Inc. | 733bbb26-7698-4a1b-9dc8-7e3490ffc92b | 2026-04-17 | Warnings | 451W47IQ8X |
| Thyroid HP | BARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS) | BioActive Nutritional, Inc. | 3795820a-cf2a-4094-9a02-70e3757b7510 | 2026-04-17 | Warnings | 451W47IQ8X |
| DIANEAL Low Calcium with Dextrose | SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE | Vantive US Healthcare LLC | aa268d3f-7389-4f25-801f-5d4825495f08 | 2026-04-16 | Warnings, Adverse reactions | 451W47IQ8X |
| PEG 3350 and Electrolytes | POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE | Wilshire Pharmaceuticals, Inc. | b251752d-7750-482a-9364-0acf4ad47cc8 | 2026-04-16 | Warnings, Adverse reactions | 451W47IQ8X |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 99c6a1a9-cadf-435b-a332-ccc189afdfa9 | 2026-04-16 | Warnings, Adverse reactions | 451W47IQ8X |
| GoLYTELY | POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE | Azurity Pharmaceuticals, Inc. | 7609ecf7-0ce0-4fbb-9c27-30987f689575 | 2026-04-15 | Warnings, Adverse reactions | 451W47IQ8X |
| TRILYTE | POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE | Aurobindo Pharma Limited | 79f5e596-8d51-4227-afcc-f5e341150957 | 2026-04-15 | Warnings, Adverse reactions | 451W47IQ8X |
| Anxiety Relief | ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUM | NaturalCare | 9f982e89-655c-49be-85d8-4099a02ed021 | 2026-04-15 | Warnings | 451W47IQ8X |
| PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride | POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE | Wilshire Pharmaceuticals, Inc. | 4e442a72-b13b-4869-8a1d-59356095b091 | 2026-04-14 | Warnings, Adverse reactions | 451W47IQ8X |
| SODIUM CHLORIDE 1 GRAM | SODIUM CHLORIDE | Gendose Pharmaceuticals, LLC | ce988ae5-61c6-4324-90e1-a94c8a54d0d0 | 2026-04-13 | Warnings | 451W47IQ8X |
| Quantum Resonance | ALCOHOLUS, 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 ALBUM | Deseret Biologicals, Inc. | f94a10bd-1c40-42c7-b458-b58070614549 | 2026-04-10 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.