NDC 63323-010-01 - Gentamicin
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
- 63323-010
- Requested NDC
- 63323-010-01
- Package NDCs from labels
- 63323-010-96, 63323-010-41, 63323-010-94, 63323-010-42, 63323-010-95, 63323-010-01, 63323-010-02, 63323-010-03, 63323-010-20
- Manufacturer
- Henry Schein, Inc
- Effective date
- 2025-10-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Gentamicin - Henry Schein, Inc | Henry Schein, Inc | 2025-10-31 | HUMAN PRESCRIPTION DRUG LABEL |
| Gentamicin - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2024-10-11 | HUMAN PRESCRIPTION DRUG LABEL |
| Gentamicin Injection, USP | REMEDYREPACK INC. | 2024-10-10 | HUMAN PRESCRIPTION DRUG LABEL |
| GENTAMICIN - HF Acquisition Co LLC, DBA HealthFirst | HF Acquisition Co LLC, DBA HealthFirst | 2024-01-30 | HUMAN PRESCRIPTION DRUG LABEL |
| Gentamicin - Medical Purchasing Solutions, LLC | Medical Purchasing Solutions, LLC | 2023-11-10 | HUMAN PRESCRIPTION DRUG LABEL |
| Gentamicin - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2023-10-31 | HUMAN PRESCRIPTION DRUG LABEL |
| Gentamicin - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2023-10-20 | HUMAN PRESCRIPTION DRUG LABEL |
| Gentamicin - General Injectables & Vaccines, Inc | General Injectables & Vaccines, Inc | 2022-12-22 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-010-01 | Gentamicin | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | 7 | |
| 63323-010-02 | Gentamicin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 7 | |
| 63323-010-03 | Gentamicin | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | 7 | |
| 63323-010-20 | Gentamicin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 7 | |
| 63323-010-41 | Gentamicin | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | 4 | |
| 63323-010-42 | Gentamicin | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | 4 | |
| 63323-010-94 | Gentamicin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 4 | |
| 63323-010-95 | Gentamicin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 4 | |
| 63323-010-96 | Gentamicin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 3 | |
| 63323-010-96 | Gentamicin | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-010 | GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ] | 7 | Current NDC, Legacy NDC, 4 package rows | 20231215_a73a5453-c091-43fd-aae2-d992152363b1.zip |
| 63323-010 | GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ] | 4 | Current NDC, Legacy NDC, 4 package rows | 20231219_0cce2238-28d3-4280-b520-ffc3067a2ffa.zip |
| 63323-010 | GENTAMICIN (GENTAMICIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241017_84f5c763-1cd3-4d85-9afb-934db8666fbf.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-010-01 | ML - Milliliter | 63323-010 | 8f7fbb9f-e4ee-4c24-9cbf-cf5bb8b1d5fa | 1 | 2021-11-09 |
| 63323-010-02 | ML - Milliliter | 63323-010 | 92538238-da65-4ed7-8897-630760fe2e7c | 1 | 2013-02-13 |
| 63323-010-03 | ML - Milliliter | 63323-010 | 19616f55-e7a5-4305-8fdd-aa5fe3efe73c | 1 | 2021-10-08 |
| 63323-010-20 | ML - Milliliter | 63323-010 | c14a0d40-777c-4160-864c-67db4bc4ef43 | 1 | 2013-02-13 |
| 63323-010-41 | ML - Milliliter | 63323-010 | 4a00898e-ee4d-42cf-ac5d-a838db4deae9 | 1 | 2021-11-09 |
| 63323-010-42 | ML - Milliliter | 63323-010 | 12f4a20a-beb2-4941-b432-2e768988c155 | 1 | 2021-11-09 |
| 63323-010-94 | ML - Milliliter | 63323-010 | 68aa80b2-bd39-4e78-ba34-50985d84379c | 1 | 2013-12-02 |
| 63323-010-95 | ML - Milliliter | 63323-010 | 2f852c4c-085f-4c84-ab61-7553ed9f830c | 1 | 2013-12-02 |
| 63323-010-96 | ML - Milliliter | 63323-010 | fc20bbf7-9d1b-4004-a475-7c44486c15dd | 1 | 2014-02-04 |
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 |
|---|---|---|---|---|---|---|
| Crane Safety Eye Wash | WATER SOLUTION | Crane Safety LLC | 96d8dda9-6cd6-3f68-e053-2995a90a0da2 | 2024-11-08 | Warnings | 059QF0KO0R |
| RUGBY EYE WASH | WATER, PURIFIED | A-S Medication Solutions | 0773e558-2f46-494c-888a-3bc517202b65 | 2024-11-08 | Warnings | 059QF0KO0R |
| Addiclenz | BOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Deseret Biologicals, Inc. | 8a3b75ca-8fec-4318-8a55-8bde0b82637d | 2024-10-31 | Warnings | Z8IX2SC1OH A2I8C7HI9T |
| Progenite | AMMONIUM CARBONICUM, BARYTA MURIATICA, BORAX, CAULOPHYLLUM THALICTROIDES, NATRUM CARBONICUM, SABAL SERRULATA, SABINA, SULPHURICUM ACIDUM, THIOSINAMINUM, FOLLICULINUM, TUBA UTERINA SUIS, UTERUS SUIS, HYPOTHALAMUS (SUIS), THYROIDINUM (SUIS), AGNUS CASTUS, CONIUM MACULATUM, GRAPHITES, HYOSCYAMUS NIGER, SEPIA, SELENIUM METALLICUM, X-RAY | Deseret Biologicals | dfc114e0-34d4-4ae4-bba8-a8a1b7ad6a24 | 2024-10-23 | Warnings | O40UQP6WCF |
| EyS Eye Wash | WATER | Eyes-Plus LLC | 1443f6bf-3a77-4a19-8585-0ec58efe042f | 2024-10-15 | Warnings | 059QF0KO0R |
| Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | 63413469-c676-48a3-a945-7d2489b535ef | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | ANDA062366 8X7386QRLV |
| Gentamicin | GENTAMICIN SULFATE | Fresenius Kabi USA, LLC | 84f5c763-1cd3-4d85-9afb-934db8666fbf | 2024-10-11 | Boxed warning, Warnings, Adverse reactions | ANDA062366 63323-010-96 63323-010 313996 092ee018-3026-4c10-a751-2043e980b09f 84f5c763-1cd3-4d85-9afb-934db8666fbf 8X7386QRLV |
| Eye Wash | WATER SOLUTION | Kroger Company | 354402ad-581d-47e7-9fd3-933bef281ff4 | 2024-10-11 | Warnings | 059QF0KO0R |
| Eye Wash | WATER | Hubei Changjian Medical Products Co., Ltd. | d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea | 2024-10-11 | Warnings | 059QF0KO0R |
| Household Detox | PTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLON | Deseret Biologicals, Inc. | 7e32c1f4-c88e-43d0-9f6c-de736d358d46 | 2024-09-27 | Warnings | A2I8C7HI9T |
| Gentamicin Sulfate | GENTAMICIN SULFATE | NuCare Pharmaceuticals, Inc. | 4add8f7b-48f0-6b6a-e054-00144ff88e88 | 2024-08-14 | Warnings, Adverse reactions | 8X7386QRLV |
| Empathy | AETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATA | Deseret Biologicals, Inc. | a89067c1-ef12-49da-8fa6-e65ff664f497 | 2024-08-13 | Warnings | 059QF0KO0R |
| Mind Detox and Drainage | ALUMINA, BARYTA CARBONICA, CARBONEUM SULPHURATUM, CEREBRUM SUIS, CONIUM MACULATUM, HELLEBORUS NIGER, LECITHIN, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PICRICUM ACIDUM, PLATINUM METALLICUM, SILICEA, STRAMONIUM, SULPHURICUM ACIDUM, ZINCUM PHOSPHORATUM | Deseret Biologicals, Inc. | 1ac1e955-a374-4cac-b997-51c6aef8d35d | 2024-08-01 | Warnings | O40UQP6WCF |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Bausch & Lomb Incorporated | 41d01350-5c4b-42fc-be5f-986ceec02bd3 | 2024-07-22 | Warnings, Adverse reactions | 8X7386QRLV |
| Thompson Safety Eyewash | WATER | Thompson Safety | 1d0e96cf-245b-cfb7-e063-6294a90a4ced | 2024-07-12 | Warnings | 059QF0KO0R |
| Gentamicin Sulfate | GENTAMICIN SULFATE | NuCare Pharmaceuticals,Inc. | 82595309-304e-a221-e053-2991aa0ac0a9 | 2024-06-14 | Warnings, Adverse reactions | 8X7386QRLV |
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | NuCare Pharmaceuticals,Inc. | 85424b40-5c2d-421d-e053-2991aa0a7771 | 2024-06-14 | Warnings, Adverse reactions | 8X7386QRLV |
| Eyesaline Emergency Eyewash | PURIFIED WATER | Honeywell Safety Products USA, Inc. | ad42a7e3-84ea-390d-e053-2a95a90a3a32 | 2024-06-14 | Warnings | 059QF0KO0R |
| Eyes Alive Eye Wash | WATER | RIVIERA PHARMA INC | 081079f4-1c06-4054-b771-00fedaa666f6 | 2024-06-05 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Becton Dickinson and Company | 6e43c5a3-dad2-49ed-b500-964cb4563cc9 | 2024-05-31 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.