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 |
|---|---|---|---|---|---|---|
| Gentamicin | GENTAMICIN SULFATE | Henry Schein, Inc | 84f6eb1c-a287-489a-8c3e-aa5954cf1992 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | ANDA062366 0404-9866-20 0404-9866 313996 65ca54d7-de8c-4c5f-b47e-393f24de2af9 84f6eb1c-a287-489a-8c3e-aa5954cf1992 8X7386QRLV |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Henry Schein, Inc. | 913a36c3-50d6-429a-a8dd-a03126d2ca08 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | 8X7386QRLV |
| Sterile Water | WATER | ICU Medical Inc. | 1c0bbcb7-5ed6-4ee7-b297-080d3359474e | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Bacteriostatic Water | WATER | Henry Schein, Inc. | a833502e-a622-4e81-8c58-cef6ccb6c4c9 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Becton Dickinson and Company | cab03cda-4660-4020-a3be-bf86242ff664 | 2025-10-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Skinade MD INsupport | ARNICA, LEDUM, CALENDULA, BELLIS PERENNIS, HYPERICUM PERF. SULPH.AC., THIOSINAMINUM, VIT.K1 | Bottled Science, Inc. | eb0069b3-8f68-3f41-e053-2995a90adbac | 2025-10-16 | Warnings | O40UQP6WCF |
| Xpect Eyewash | EYEWASH | Cintas Corporation | 1d69365d-662b-4248-8fa9-1629451b549a | 2025-09-30 | Warnings | 059QF0KO0R |
| CheBoho TEA TREE ACNE | CHEBOHO TEA TREE ACNE | Opalshi(Guangzhou)E-commerce Co. Ltd. | 3fc4cf84-b2da-c593-e063-6394a90abc5c | 2025-09-27 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | ProPharma Distribution | 3f2ae880-852f-b45d-e063-6394a90aa1cc | 2025-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| Medi-First First Aid Eye Wash | PURIFIED WATER | Unifirst First Aid Corporation | dcd7fe56-ff5c-4c8d-a415-6e363d7e53f4 | 2025-09-08 | Warnings | 059QF0KO0R |
| Green Guard First Aid Eye Wash | WATER | Unifirst First Aid Corporation | a4ba5526-b4e2-4bcc-9127-aa22ebf5017f | 2025-09-08 | Warnings | 059QF0KO0R |
| Medi-First Plus First Aid Eye Wash | WATER | Unifirst First Aid Corporation | d7ea80ca-b4a0-4476-8b50-b3425c6d456a | 2025-09-08 | Warnings | 059QF0KO0R |
| ECOLAB Eye Wash | PURIFIED WATER | ECOLAB Food Safety Specialties, Inc. | 4bcfa21a-791e-4d04-e054-00144ff88e88 | 2025-09-08 | Warnings | 059QF0KO0R |
| Physicians Care Eyewash | EYEWASH | Acme United Corporation | 3e239b12-9a75-339d-e063-6294a90a72ae | 2025-09-06 | Warnings | 059QF0KO0R |
| Sterile Water | WATER INJECTION | Henry Schein, Inc. | 3501952b-b556-4d5e-b81b-5c35ff87b475 | 2025-08-28 | Warnings, Adverse reactions | 059QF0KO0R |
| Fungus Fighter | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 93e05175-001b-c639-e053-2a95a90a289c | 2025-08-19 | Warnings | O40UQP6WCF |
| Fungus Fighter | CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC. | Newton Laboratories, Inc. | 9b4276af-b738-3293-e053-2a95a90ad022 | 2025-08-19 | Warnings | O40UQP6WCF |
| 3afe5090-6307-2ec7-e063-6394a90a68e2 | 912f1631-2e68-4f37-bfd3-121b55fa2ee9 | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | 912f1631-2e68-4f37-bfd3-121b55fa2ee9 | ||
| Phytogel | ARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, BELLIS PERENNIS, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, LEDUM PALUSTRE, NATRUM SULPHURICUM, RHUS TOX, SULPHURICUM ACIDUM, SYMPHYTUM OFFICINALE | Energetix Corporation | e94b4f4c-bf4e-4210-a4e1-f2b7341e6dcc | 2025-07-15 | Warnings | O40UQP6WCF |
| Sterile Water | STERILE WATER | Nephron Pharmaceuticals Corporation | bc04a883-babc-87a6-e053-2995a90a3dfd | 2025-07-11 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.