Linezolid
- Product NDC
- 0143-9534
- 11-digit product format
- 001439534
- Labeler code
- 0143
- Product ID
- 0143-9534_22fd37ba-a112-4fb2-a595-d571232c792e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Linezolid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA206454
- Marketing category
- ANDA
- Marketing start
- 2022-12-27
- 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 |
|---|
| 0143-9534-10 | Linezolid | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 12 |
| 0143-9534-10 | Linezolid | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9534 | LINEZOLID INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240824_fedbffa7-087d-4448-85c9-0350a3947080.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 |
|---|
| 0143-9534-10 | 00143953410 | 10 POUCH in 1 BOX (0143-9534-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG | 10 pouch | 2022-12-27 | 0000-00-00 | No | No | Current |