Linezolid
- Product NDC
- 0781-3431
- 11-digit product format
- 007813431
- Labeler code
- 0781
- Product ID
- 0781-3431_731258b6-fb75-4612-b7e6-cfec8f312aaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Linezolid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sandoz Inc
- Application
- ANDA200904
- Marketing category
- ANDA
- Marketing start
- 2016-06-15
- Substance
- LINEZOLID
- Active strength
- 200 mg/100mL
- Pharmacologic classes
- Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Linezolid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LINEZOLID | 200 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ISQ9I6J12J |
| Rxcui | 1662278, 1662285 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-3431-46 | Linezolid | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 18 |
| 0781-3431-95 | Linezolid | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-3431 | LINEZOLID INJECTION, SOLUTION [SANDOZ INC] | 18 | Current NDC, Legacy NDC, 2 package rows | 20240830_a287cdf4-47a8-459f-8890-86181af5e836.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 |
|---|
| 0781-3431-46 | 00781343146 | 100 mL in 1 BAG (0781-3431-46) | 100 ml | 2016-06-15 | 0000-00-00 | No | No | Current |
| 0781-3431-95 | 00781343195 | 10 BAG in 1 CARTON (0781-3431-95) > 100 mL in 1 BAG | 10 bag | 2016-06-15 | 0000-00-00 | No | No | Current |