Linezolid
- Product NDC
- 57664-682
- 11-digit product format
- 576640682
- Labeler code
- 57664
- Product ID
- 57664-682_2e599906-ac35-54ab-e063-6394a90ac605
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- linezolid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA207354
- Marketing category
- ANDA
- Marketing start
- 2017-02-01
- 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 |
|---|
| 57664-682-30 | Linezolid | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57664-682 | LINEZOLID INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 19 | Current NDC, Legacy NDC, 1 package rows | 20250221_870c9600-04d5-4b44-a5b5-02252a310f22.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 |
|---|
| 57664-682-30 | 57664068230 | 100 mL in 1 BAG (57664-682-30) | 100 ml | 2017-02-01 | 0000-00-00 | No | No | Current |