Linezolid
- Product NDC
- 65145-181
- 11-digit product format
- 651450181
- Labeler code
- 65145
- Product ID
- 65145-181_2220c753-e0e8-4797-bce2-34b3c63bd631
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- linezolid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Caplin Steriles Limited
- Application
- ANDA219558
- Marketing category
- ANDA
- Marketing start
- 2025-12-23
- Substance
- LINEZOLID
- Active strength
- 600 mg/300mL
- 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 | 600 mg/300mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ISQ9I6J12J |
| Rxcui | 1662285 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65145-181-01 | Linezolid | 300 mL in 1 BAG | INJECTION, SOLUTION | 300 | | 1 |
| 65145-181-01 | Linezolid | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 1 |
| 65145-181-10 | Linezolid | 10 in 1 CASE | INJECTION, SOLUTION | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65145-181-01 | 65145018101 | 300 mL in 1 BAG | 300 ml | | | | Historical |
| 65145-181-10 | 65145018110 | 10 POUCH in 1 CASE (65145-181-10) / 1 BAG in 1 POUCH (65145-181-01) / 300 mL in 1 BAG | 10 pouch | 2025-12-23 | No | No | Current |