Linezolid
- Product NDC
- 33342-352
- 11-digit product format
- 333420352
- Labeler code
- 33342
- Product ID
- 33342-352_90dd8c13-c428-4472-91e5-5b1fcdc4fce3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Linezolid
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA210378
- Marketing category
- ANDA
- Marketing start
- 2024-10-10
- 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 |
|---|
| 33342-352-11 | Linezolid | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 1 |
| 33342-352-31 | Linezolid | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | | 1 |
| 33342-352-31 | Linezolid | 5 in 1 CARTON | TABLET, COATED | 5 | | 1 |
| 33342-352-32 | Linezolid | 20 in 1 BOTTLE | TABLET, COATED | 20 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-352 | LINEZOLID TABLET, COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 4 package rows | 20241129_90dd8c13-c428-4472-91e5-5b1fcdc4fce3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-352-11 | 33342035211 | 100 TABLET, COATED in 1 BOTTLE (33342-352-11) | | 2024-10-10 | No | No | Current |
| 33342-352-31 | 33342035231 | 5 BLISTER PACK in 1 CARTON (33342-352-31) / 10 TABLET, COATED in 1 BLISTER PACK | 5 blister pack | 2024-10-10 | No | No | Current |
| 33342-352-32 | 33342035232 | 20 TABLET, COATED in 1 BOTTLE (33342-352-32) | | 2024-10-10 | No | No | Current |