Linezolid
- Product NDC
- 43386-022
- 11-digit product format
- 433860022
- Labeler code
- 43386
- Product ID
- 43386-022_74f11ed7-8e21-4310-975e-f88609d5aa4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Linezolid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA207526
- Marketing category
- ANDA
- Marketing start
- 2016-08-22
- 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 |
|---|
| 43386-022-02 | Linezolid | 20 in 1 BOTTLE | TABLET | 20 | | 5 |
| 43386-022-05 | Linezolid | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
| 43386-022-30 | Linezolid | 10 in 1 BLISTER PACK | TABLET | 10 | | 5 |
| 43386-022-31 | Linezolid | 3 in 1 CARTON | TABLET | 3 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-022 | LINEZOLID TABLET [LUPIN PHARMACEUTICALS,INC.] | 5 | Current NDC, 4 package rows | 20241204_b3c55eb4-50f2-47f0-a424-5a6779518e1d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43386-022-02 | 43386002202 | 20 in 1 BOTTLE | Historical |
| 43386-022-05 | 43386002205 | 500 in 1 BOTTLE | Historical |
| 43386-022-30 | 43386002230 | 10 in 1 BLISTER PACK | Historical |
| 43386-022-31 | 43386002231 | 3 in 1 CARTON | Historical |