Tobramycin Inhalation
- Product NDC
- 66993-195
- 11-digit product format
- 669930195
- Labeler code
- 66993
- Product ID
- 66993-195_43a62e66-8821-40b6-85dd-0f29fe4adc8c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tobramycin inhalation
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Prasco, LLC
- Application
- NDA201820
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-09-15
- Substance
- TOBRAMYCIN
- Active strength
- 300 mg/4mL
- 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 Inhalation
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOBRAMYCIN | 300 mg/4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZ8RRZ51VK |
| Rxcui | 1314763 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66993-195-94 | Tobramycin Inhalation | 14 in 1 CARTON | SOLUTION | 14 | | 5 |
| 66993-195-94 | Tobramycin Inhalation | 4 in 1 POUCH | SOLUTION | 4 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66993-195 | TOBRAMYCIN INHALATION SOLUTION [PRASCO, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230223_b5b51665-c427-42b9-bd6e-6e3c06f650e1.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 |
|---|
| 66993-195-94 | 66993019594 | 14 POUCH in 1 CARTON (66993-195-94) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE | 14 pouch | 2020-09-15 | 0000-00-00 | No | No | Current |