Linezolid
- Product NDC
- 64980-561
- 11-digit product format
- 649800561
- Labeler code
- 64980
- Product ID
- 64980-561_e7ccafc3-f287-4339-97d5-883922f99c74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Linezolid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA078845
- Marketing category
- ANDA
- Marketing start
- 2023-11-20
- 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 |
|---|
| 64980-561-02 | Linezolid | 20 in 1 BOTTLE | TABLET | 20 | | 2 |
| 64980-561-03 | Linezolid | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-561 | LINEZOLID TABLET [RISING PHARMA HOLDINGS, INC.] | 2 | Current NDC, 2 package rows | 20241208_bf4fa35d-93c9-41c3-a2ae-0298014b8a9f.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 |
|---|
| 64980-561-02 | 64980056102 | 20 TABLET in 1 BOTTLE (64980-561-02) | 20 tablet | 2023-11-20 | No | No | Current |
| 64980-561-03 | 64980056103 | 30 TABLET in 1 BOTTLE (64980-561-03) | 30 tablet | 2023-11-20 | No | No | Current |