Cephalexin
- Product NDC
- 53002-2540
- 11-digit product format
- 530022540
- Labeler code
- 53002
- Product ID
- 53002-2540_bc53ef7e-3d8b-4fef-99eb-3b8d3509aac8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cephalexin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA062703
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 0000-00-00
- Substance
- CEPHALEXIN
- Active strength
- 250 mg/5mL
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-2540-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-e8a5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971 |
| 53002-2540-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-e8a5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971 |
| 53002-2540-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-e8a5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971 |
| 53002-2540-2 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-e8a5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971 |
| 53002-2540-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e8a5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971 |
| 53002-2540-2 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e8a5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971 |
| 53002-2540-1 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-e8a5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971 |
| 53002-2540-2 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-e8a5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971 |
| 53002-2540-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e8a5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971 |
| 53002-2540-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e8a5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral use Initial U.S. Approval: 1971 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2540-1 | Cephalexin | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | | 8 |
| 53002-2540-2 | Cephalexin | 200 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 200 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2540 | CEPHALEXIN CAPSULE CEPHALEXIN POWDER, FOR SUSPENSION [RPK PHARMACEUTICALS, INC.] | 8 | Legacy NDC, 2 package rows | 20230609_3b1a58b4-8a3f-4053-ad60-eff02200b178.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 |
|---|
| 53002-2540-1 | 53002254001 | 100 mL in 1 BOTTLE (53002-2540-1) | 100 ml | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-2540-2 | 53002254002 | 200 mL in 1 BOTTLE (53002-2540-2) | 200 ml | 2018-10-01 | 0000-00-00 | No | No | Current |