Tobramycin
- Product NDC
- 76204-029
- 11-digit product format
- 762040029
- Labeler code
- 76204
- Product ID
- 76204-029_459f9e6a-cdbc-32cb-e063-6294a90a03e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Ritedose Pharmaceuticals, LLC
- Application
- ANDA201422
- Marketing category
- ANDA
- Marketing start
- 2025-03-25
- Substance
- TOBRAMYCIN
- Active strength
- 300 mg/5mL
- 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 | 300 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZ8RRZ51VK |
| Rxcui | 348719 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76204-029-56 | Tobramycin | 4 in 1 POUCH | SOLUTION | 4 | | 3 |
| 76204-029-56 | Tobramycin | 14 in 1 CARTON | SOLUTION | 14 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76204-029 | TOBRAMYCIN SOLUTION [RITEDOSE PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20250327_e8205898-0162-4e6c-bcf1-87cb074ab9ae.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76204-029-56 | 76204002956 | 14 POUCH in 1 CARTON (76204-029-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE | 14 pouch | 2025-03-25 | No | No | Current |