Linezolid
- Product NDC
- 0904-6553
- 11-digit product format
- 009046553
- Labeler code
- 0904
- Product ID
- 0904-6553_a9f1f648-96d9-4994-a0cf-7f3ff4da1c19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Linezolid
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA205517
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- Substance
- LINEZOLID
- Active strength
- 600 mg/1
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ISQ9I6J12J |
| Rxcui | 311347 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6553-04 | Linezolid | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 4 |
| 0904-6553-04 | Linezolid | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6553 | LINEZOLID TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20210121_bef116a8-427d-4855-86de-0017e01430b0.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 |
|---|
| 0904-6553-04 | 00904655304 | 30 BLISTER PACK in 1 CARTON (0904-6553-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2015-12-21 | 0000-00-00 | No | No | Current |