Tobramycin
- Product NDC
- 72603-160
- 11-digit product format
- 726030160
- Labeler code
- 72603
- Product ID
- 72603-160_3f7a227f-2fe6-52d8-e063-6294a90a2838
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tobramycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Northstar Rx LLC
- Application
- ANDA211189
- Marketing category
- ANDA
- Marketing start
- 2024-04-01
- Substance
- TOBRAMYCIN SULFATE
- Active strength
- 1.2 g/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 | 1.2 g/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 |
|---|
| 72603-160-01 | Tobramycin | 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, POWDER, LYOPHILIZED, | 50 | | 3 |
| 72603-160-06 | Tobramycin | 6 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 6 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-160 | TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NORTHSTAR RX LLC] | 2 | Current NDC, 2 package rows | 20240402_55d09ffd-4f32-8aeb-3904-8a17db635e3a.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 |
|---|
| 72603-160-01 | 72603016001 | 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | 50 ml | | | | Historical |
| 72603-160-06 | 72603016006 | 6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72603-160-06) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (72603-160-01) | | 2024-04-01 | No | No | Historical |