Tobramycin
- Product NDC
- 63323-307
- 11-digit product format
- 633230307
- Labeler code
- 63323
- Product ID
- 63323-307_f600dca6-dba3-4c03-8d55-15f8dbd467fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOBRAMYCIN SULFATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA065120
- Marketing category
- ANDA
- Marketing start
- 2004-11-30
- Marketing end
- 0000-00-00
- Substance
- TOBRAMYCIN SULFATE
- Active strength
- 40 mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 | |
| 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 |
|---|
| 63323-307 | TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 5 | Legacy NDC | 20240209_8cfeb84f-193a-458a-bdec-205d9274e1a4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-307-51 | 63323030751 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (63323-307-51) > 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | 2004-11-30 | 0000-00-00 | No | No | Current |