TOBRAMYCIN
- Product NDC
- 59651-129
- 11-digit product format
- 596510129
- Labeler code
- 59651
- Product ID
- 59651-129_faec0c96-e264-6fee-e053-6394a90a23ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOBRAMYCIN
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA210871
- Marketing category
- ANDA
- Marketing start
- 2021-01-22
- 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 |
|---|
| 59651-129-04 | TOBRAMYCIN | 4 in 1 POUCH | SOLUTION | 4 | | 6 |
| 59651-129-04 | TOBRAMYCIN | 5 mL in 1 AMPULE | SOLUTION | 5 | | 6 |
| 59651-129-56 | TOBRAMYCIN | 14 in 1 CARTON | SOLUTION | 14 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-129 | TOBRAMYCIN SOLUTION [AUROBINDO PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 3 package rows | 20230520_0aa5859e-cd80-49c0-881b-47f39d1f1d01.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 |
|---|
| 59651-129-04 | 59651012904 | 4 in 1 POUCH | | | | | | Historical |
| 59651-129-56 | 59651012956 | 14 POUCH in 1 CARTON (59651-129-56) / 4 AMPULE in 1 POUCH (59651-129-04) / 5 mL in 1 AMPULE | 14 pouch | 2021-01-22 | 0000-00-00 | No | No | Current |