Tobramycin Inhalation Solution
- Product NDC
- 43598-605
- 11-digit product format
- 435980605
- Labeler code
- 43598
- Product ID
- 43598-605_946d18e8-ea8f-97c0-f49b-ec4e286beede
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin Inhalation Solution
- Dosage form
- INHALANT
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA207080
- Marketing category
- ANDA
- Marketing start
- 2019-05-14
- 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 Inhalation Solution
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-605 | TOBRAMYCIN INHALATION SOLUTION INHALANT [DR. REDDY'S LABORATORIES INC.] | 12 | Current NDC, Legacy NDC | 20230420_e5bbf589-d066-c89a-c40f-cbeb6f98c5b5.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 |
|---|
| 43598-605-56 | 43598060556 | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE | 14 pouch | 2019-05-14 | 0000-00-00 | No | No | Current |
| 43598-605-58 | 43598060558 | 56 POUCH in 1 CARTON (43598-605-58) / 1 AMPULE in 1 POUCH (43598-605-11) / 5 mL in 1 AMPULE | 56 pouch | 2020-10-29 | 0000-00-00 | No | No | Current |