Linezolid
- Product NDC
- 0054-0319
- 11-digit product format
- 000540319
- Labeler code
- 0054
- Product ID
- 0054-0319_ea8ff456-80d5-4f40-b397-a25b31a77947
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- linezolid
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA200068
- Marketing category
- ANDA
- Marketing start
- 2015-06-03
- Substance
- LINEZOLID
- Active strength
- 100 mg/5mL
- 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 | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ISQ9I6J12J |
| Rxcui | 311345 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0319-50 | Linezolid | 150 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 150 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LINEZOLID | ACTIVE INGREDIENT | ISQ9I6J12J | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| LINEZOLID | ACTIVE MOIETY | ISQ9I6J12J | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | LINEZOLID FOR ORAL SOLUTION (LINEZOLID) POWDER, FOR SUSPENSION [ROXANE LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0319 | LINEZOLID POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICALS USA INC.] | 16 | Current NDC, Legacy NDC, 1 package rows | 20250212_16007ca5-7956-4414-af38-406a6623400e.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 |
|---|
| 0054-0319-50 | 00054031950 | 150 mL in 1 BOTTLE (0054-0319-50) | 150 ml | 2015-06-03 | 0000-00-00 | No | No | Current |