Xenleta
- Product NDC
- 72000-110
- 11-digit product format
- 720000110
- Labeler code
- 72000
- Product ID
- 72000-110_772b4b36-4627-4087-8a16-c1ed771939c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lefamulin acetate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Nabriva Therapeutics US, Inc.
- Application
- NDA211672
- Marketing category
- NDA
- Marketing start
- 2019-09-09
- Marketing end
- 0000-00-00
- Substance
- LEFAMULIN ACETATE
- Active strength
- 600 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72000-110-10 | Xenleta | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | | 9 |
| 72000-110-30 | Xenleta | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72000-110 | XENLETA (LEFAMULIN ACETATE) INJECTION, SOLUTION CITRIC BUFFERED NORMAL SALINE (ANHYDROUS CITRIC ACID) INJECTION, SOLUTION XENLETA (LEFAMULIN ACETATE) TABLET, COATED [NABRIVA THERAPEUTICS US, INC.] | 9 | Legacy NDC, 2 package rows | 20241013_101db63d-2fe2-48df-8506-1382d6dcd4a3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72000-110-10 | 72000011010 | 10 TABLET, COATED in 1 BLISTER PACK (72000-110-10) | 2019-09-09 | 0000-00-00 | No | No | Current |
| 72000-110-30 | 72000011030 | 30 TABLET, COATED in 1 BOTTLE (72000-110-30) | 2019-09-09 | 0000-00-00 | No | No | Current |