Linezolid
- Product NDC
- 31722-865
- 11-digit product format
- 317220865
- Labeler code
- 31722
- Product ID
- 31722-865_05657697-e108-9eaf-e063-6294a90a5d97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Linezolid
- Dosage form
- GRANULE, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA211813
- Marketing category
- ANDA
- Marketing start
- 2022-10-31
- 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 |
|---|
| 31722-865-25 | Linezolid | 150 mL in 1 BOTTLE, GLASS | GRANULE, FOR SUSPENSION | 150 | | 2 |
| 31722-865-25 | Linezolid | 1 in 1 CARTON | GRANULE, FOR SUSPENSION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-865 | LINEZOLID (LINEZOLID) GRANULE, FOR SUSPENSION [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230926_a89a37ec-a736-464b-a83a-84bef6ccd702.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 31722-865-25 | 31722086525 | 1 BOTTLE, GLASS in 1 CARTON (31722-865-25) / 150 mL in 1 BOTTLE, GLASS | 2022-10-31 | 0000-00-00 | No | No | Current |