Cephalexin
- Product NDC
- 51655-028
- 11-digit product format
- 516550028
- Labeler code
- 51655
- Product ID
- 51655-028_4768d6e6-d4ee-0e49-e063-6394a90adbc9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cephalexin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northwind Pharmaceuticals, LLC
- Application
- ANDA090836
- Marketing category
- ANDA
- Marketing start
- 2014-11-06
- Marketing end
- 2026-08-31
- Substance
- CEPHALEXIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cephalexin
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CEPHALEXIN | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OBN7UDS42Y |
| Rxcui | 309114 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 51655-028-20 | 2026-01-02 | C162847 | 48780-1 | 9d75b9d1-14e8-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971 |
| 51655-028-52 | 2026-01-02 | C162847 | 48780-1 | 9d75b9d1-14e8-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971 |
| 51655-028-20 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-14e8-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971 |
| 51655-028-52 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-14e8-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971 |
| 51655-028-20 | 2020-07-01 | C162847 | 48780-1 | 9d75b9d1-14e8-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971 |
| 51655-028-52 | 2020-07-01 | C162847 | 48780-1 | 9d75b9d1-14e8-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971 |
| 51655-028-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-14e8-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, for oral use Initial U.S. Approval: 1971 |
| 51655-028-52 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-14e8-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CEPHALEXIN CAPSULES safely and effectively. See full prescribing information for CEPHALEXIN CAPSULES. CEPHALEXIN capsules, 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 |
|---|
| 51655-028-20 | Cephalexin | 20 in 1 BOTTLE, DISPENSING | CAPSULE | 20 | | 4 |
| 51655-028-52 | Cephalexin | 30 in 1 BOTTLE, DISPENSING | CAPSULE | 30 | | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-028 | CEPHALEXIN CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220101_89bb3920-69bf-4818-b573-4bd845f6e2d5.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 |
|---|
| 51655-028-20 | 51655002820 | 20 CAPSULE in 1 BOTTLE, DISPENSING (51655-028-20) | 20 capsule | 2014-11-06 | 2026-08-31 | No | No | Current |
| 51655-028-52 | 51655002852 | 30 CAPSULE in 1 BOTTLE, DISPENSING (51655-028-52) | 30 capsule | 2014-11-06 | 0000-00-00 | No | No | Current |