Tobramycin
- Product NDC
- 63323-303
- 11-digit product format
- 633230303
- Labeler code
- 63323
- Product ID
- 63323-303_473ebf35-f2d4-46fb-9463-3fe402309c01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOBRAMYCIN SULFATE
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA050789
- Marketing category
- NDA
- Marketing start
- 2005-11-23
- Substance
- TOBRAMYCIN SULFATE
- Active strength
- 1200 mg/30mL
- 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 | 1200 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HJT0RXD7JK |
| Rxcui | 597823 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-303-01 | Tobramycin | 30 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, POWDER, FOR SOLUTION | 30 | | 7 |
| 63323-303-51 | Tobramycin | 6 in 1 TRAY | INJECTION, POWDER, FOR SOLUTION | 6 | | 7 |
| 63323-303-21 | Tobramycin | 30 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, POWDER, FOR SOLUTION | 30 | | 3 |
| 63323-303-55 | Tobramycin | 6 in 1 TRAY | INJECTION, POWDER, FOR SOLUTION | 6 | | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-303 | TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240130_d62ff359-912b-4be1-9fc2-2dde8777eefb.zip |
| 63323-303 | TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240214_9a5cecd6-aa65-42d2-b15a-06b4fcebcc0f.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 |
|---|
| 63323-303-01 | 63323030301 | 30 mL in 1 VIAL, PHARMACY BULK PACKAGE | 30 ml | | | | | Historical |
| 63323-303-21 | 63323030321 | 30 mL in 1 VIAL, PHARMACY BULK PACKAGE | 30 ml | | | | | Historical |
| 63323-303-51 | 63323030351 | 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-51) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-303-01) | | 2005-11-23 | 0000-00-00 | No | No | Current |
| 63323-303-55 | 63323030355 | 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-55) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-303-21) | | 2005-11-23 | 0000-00-00 | No | No | Current |