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 |
|---|---|---|---|---|---|---|
| PEMF Optimizer | AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 97d57469-4c5b-4d3f-9398-3a1a6617a649 | 2024-04-23 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Hikma Pharmaceuticals USA Inc. | 78ef7ad3-451d-43d0-a9b6-5cf0aadca003 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | B. Braun Medical Inc. | 8fc8d87a-3951-4ac5-97df-c161ffc90475 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye Wash | WATER | M-star (Hubei) Health&Care Products Co., Ltd. | 71706039-e250-4f08-9687-71b2928c4e46 | 2024-04-01 | Warnings | 059QF0KO0R |
| ULINE Eyewash | EYEWASH | Uline. | 14545fc9-1fb4-befa-e063-6294a90a0474 | 2024-03-23 | Warnings | 059QF0KO0R |
| Chemtox | BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOL | Deseret Biologicals, Inc. | 91f52c95-f36d-4754-8570-f81ed8d36180 | 2024-03-06 | Warnings | O40UQP6WCF |
| GI Drainage | CINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOS | Deseret Biologicals, Inc. | ff81e3ca-2f88-4daf-a734-083107269d3a | 2024-02-21 | Warnings | 059QF0KO0R |
| Sterile Water | STERILE WATER | Chartwell RX, LLC | 3681eeaa-807a-47ca-9fbc-61c2b682800a | 2024-02-01 | 059QF0KO0R | |
| Sterile Water | WATER | A-S Medication Solutions | dba87371-31d2-47c2-ab83-89aabce4b184 | 2024-01-31 | Warnings, Adverse reactions | 059QF0KO0R |
| GENTAMICIN | GENTAMICIN | HF Acquisition Co LLC, DBA HealthFirst | c1ff0cdc-ac5d-30ca-e053-2a95a90a5066 | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | ANDA062366 51662-1508-3 51662-1508-2 51662-1508 313996 1032caaf-e8c2-e3cc-e063-6294a90a47f3 c1ff0cdc-ac5d-30ca-e053-2a95a90a5066 8X7386QRLV |
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | HF Acquisition Co LLC, DBA HealthFirst | e9fbe619-2afe-f1d7-e053-2a95a90aab29 | 2024-01-27 | Boxed warning, Warnings, Adverse reactions | 8X7386QRLV |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Padagis Israel Pharmaceuticals Ltd | a9486ae1-350b-41c5-ae0c-a4d692bb2dfd | 2024-01-15 | Adverse reactions | 8X7386QRLV |
| gentamicin sulfate | GENTAMICIN SULFATE | DIRECT RX | 51a411a0-2671-4c1c-bf25-e29b32efed0c | 2024-01-10 | Warnings, Adverse reactions | 8X7386QRLV |
| F02 ANGR-FLX | ADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLE | Apex Energetics Inc. | bc7c2bf3-8b0d-766f-e053-2a95a90ad34c | 2024-01-08 | Warnings | 059QF0KO0R |
| F09 LTGO | ADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALIS | Apex Energetics Inc. | bd1e652f-b3a4-c5bd-e053-2995a90ae03f | 2024-01-08 | Warnings | 059QF0KO0R |
| N02 PETROCHEM | ACETONE, ANILINUM, BENZINUM, BENZOPYRENE, CARBO VEGETABILIS, CARBOLICUM ACIDUM, CARBON TETRACHLORIDE, ETHER, MAGNESIA SULPHURICA, METHYL ALCOHOL, PETROLEUM, PHENOLPHTHALEIN, PHOSPHORUS, PICRICUM ACIDUM, PINE TAR, PLUMBOUS CHLORIDE, PLUMBUM METALLICUM, SULPHONALUM, SULPHURICUM ACIDUM, TEREBINTHINA, TRICHLOROETHYLENE, VANADIUM METALLICUM | Apex Energetics Inc. | ba5e7801-667b-ab7c-e053-2995a90a788c | 2024-01-08 | Warnings | O40UQP6WCF |
| Fendall 2000 Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | b56ef662-fec2-4d94-e053-2995a90aba2b | 2024-01-06 | Warnings | 059QF0KO0R |
| Gentamicin Sulfate | GENTAMICIN SULFATE | Sandoz Inc | a213fb9c-08ea-4f30-a6c9-93c7a9ba5280 | 2024-01-02 | Warnings, Adverse reactions | 8X7386QRLV |
| Leader Eye Wash | PURIFIED WATER | Cardinal Health | 8d3ad11f-1945-f838-e053-2995a90a7aa5 | 2023-12-23 | Warnings | 059QF0KO0R |
| Gentamicin | GENTAMICIN | Fresenius Kabi USA, LLC | 8bdeef7f-ad8e-46e0-a872-e945eae51d68 | 2023-12-20 | Boxed warning, Warnings, Adverse reactions | ANDA062366 8X7386QRLV |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.