Tobramycin
- Product NDC
- 63323-305
- 11-digit product format
- 633230305
- Labeler code
- 63323
- Product ID
- 63323-305_c55fcee9-70c7-4926-bee6-014c0b133249
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOBRAMYCIN SULFATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA065122
- Marketing category
- ANDA
- Marketing start
- 2004-11-30
- Substance
- TOBRAMYCIN SULFATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tobramycin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOBRAMYCIN SULFATE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HJT0RXD7JK |
| Rxcui | 313416, 597823 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-305-01 | Tobramycin | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | | 7 |
| 63323-305-02 | Tobramycin | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOBRAMYCIN SULFATE | ACTIVE INGREDIENT | HJT0RXD7JK | TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| TOBRAMYCIN | ACTIVE MOIETY | VZ8RRZ51VK | TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| PHENOL | INACTIVE INGREDIENT | 339NCG44TV | TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-305 | TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240302_d6dd9460-b030-479a-b3e3-03606e6fcad1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-305-01 | 63323030501 | 2 mL in 1 VIAL, MULTI-DOSE | 2 ml | | | | | Historical |
| 63323-305-02 | 63323030502 | 25 VIAL, MULTI-DOSE in 1 TRAY (63323-305-02) / 2 mL in 1 VIAL, MULTI-DOSE (63323-305-01) | | 2004-11-30 | 0000-00-00 | No | No | Current |