Baxdela
- Product NDC
- 70842-101
- 11-digit product format
- 708420101
- Labeler code
- 70842
- Product ID
- 70842-101_fcc371f3-3214-4036-8834-33337e7cae0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- delafloxacin meglumine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Melinta Therapeutics, LLC
- Application
- NDA208610
- Marketing category
- NDA
- Marketing start
- 2017-06-19
- Substance
- DELAFLOXACIN MEGLUMINE
- Active strength
- 450 mg/1
- Pharmacologic classes
- Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Baxdela
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DELAFLOXACIN MEGLUMINE | 450 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7V53U4U4T |
| Rxcui | 1927667, 1927672, 1927677, 1927682 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70842-101-01 | 2025-08-07 | C162847 | 48780-1 | 3b156c62-33b0-fb37-e063-e6dba90a4e07 | These highlights do not include all the information needed to use BAXDELA ® safely and effectively. See full prescribing information for BAXDELA. BAXDELA (delafloxacin) tablets, for oral use BAXDELA (delafloxacin) for injection, for intravenous use Initial U.S. Approval: 2017 |
| 70842-101-02 | 2025-08-07 | C162847 | 48780-1 | 3b156c62-33b0-fb37-e063-e6dba90a4e07 | These highlights do not include all the information needed to use BAXDELA ® safely and effectively. See full prescribing information for BAXDELA. BAXDELA (delafloxacin) tablets, for oral use BAXDELA (delafloxacin) for injection, for intravenous use Initial U.S. Approval: 2017 |
| 70842-101-05 | 2025-08-07 | C162847 | 48780-1 | 3b156c62-33b0-fb37-e063-e6dba90a4e07 | These highlights do not include all the information needed to use BAXDELA ® safely and effectively. See full prescribing information for BAXDELA. BAXDELA (delafloxacin) tablets, for oral use BAXDELA (delafloxacin) for injection, for intravenous use Initial U.S. Approval: 2017 |
| 70842-101-01 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-33b0-fb37-e063-e6dba90a4e07 | These highlights do not include all the information needed to use BAXDELA ® safely and effectively. See full prescribing information for BAXDELA. BAXDELA (delafloxacin) tablets, for oral use BAXDELA (delafloxacin) for injection, for intravenous use Initial U.S. Approval: 2017 |
| 70842-101-02 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-33b0-fb37-e063-e6dba90a4e07 | These highlights do not include all the information needed to use BAXDELA ® safely and effectively. See full prescribing information for BAXDELA. BAXDELA (delafloxacin) tablets, for oral use BAXDELA (delafloxacin) for injection, for intravenous use Initial U.S. Approval: 2017 |
| 70842-101-05 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-33b0-fb37-e063-e6dba90a4e07 | These highlights do not include all the information needed to use BAXDELA ® safely and effectively. See full prescribing information for BAXDELA. BAXDELA (delafloxacin) tablets, for oral use BAXDELA (delafloxacin) for injection, for intravenous use Initial U.S. Approval: 2017 |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70842-101 | BAXDELA (DELAFLOXACIN MEGLUMINE) TABLET BAXDELA (DELAFLOXACIN MEGLUMINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MELINTA THERAPEUTICS, LLC] | 20 | Current NDC, Legacy NDC, 6 package rows | 20250426_fb77637a-88d9-4aea-958f-e270030ce30d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70842-101-01 | 70842010101 | 1 BOTTLE in 1 CARTON (70842-101-01) / 20 TABLET in 1 BOTTLE | 1 bottle | 2017-06-19 | 0000-00-00 | No | No | Current |
| 70842-101-02 | 70842010102 | 2 BLISTER PACK in 1 CARTON (70842-101-02) / 10 TABLET in 1 BLISTER PACK (70842-101-03) | 2 blister pack | 2017-06-19 | 0000-00-00 | No | No | Current |
| 70842-101-03 | 70842010103 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 70842-101-05 | 70842010105 | 1 BLISTER PACK in 1 CARTON (70842-101-05) / 2 TABLET in 1 BLISTER PACK | 1 blister pack | 2018-05-09 | 0000-00-00 | Yes | No | Current |