Linezolid
- Product NDC
- 70518-4034
- 11-digit product format
- 705184034
- Labeler code
- 70518
- Product ID
- 70518-4034_45c15571-71e0-c60a-e063-6294a90a5eef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Linezolid
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA205517
- Marketing category
- ANDA
- Marketing start
- 2024-05-08
- 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 |
|---|
| 70518-4034-0 | Linezolid | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 4 |
| 70518-4034-1 | Linezolid | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4034 | LINEZOLID TABLET, FILM COATED [REMEDYREPACK INC.] | 1 | Current NDC, 2 package rows | 20240726_3e0d868d-f419-47e8-a3bc-41ececac468b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4034-0 | 70518403400 | 20 TABLET, FILM COATED in 1 BOTTLE (70518-4034-0) | 2024-05-08 | No | No | Current |
| 70518-4034-1 | 70518403401 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4034-1) | 2025-12-12 | No | No | Current |