cephalexin
- Product NDC
- 50436-7216
- 11-digit product format
- 504367216
- Labeler code
- 50436
- Product ID
- 50436-7216_e658080f-3de4-412a-b5fd-a21f909475aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cephalexin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA062791
- Marketing category
- ANDA
- Marketing start
- 2010-06-21
- Marketing end
- 0000-00-00
- Substance
- CEPHALEXIN
- Active strength
- 250 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dfa3f520-409c-432e-b6d3-9250d468c772 | Product name | 1 | 20250401 |
| 64bb7f1a-2c2e-4741-8301-dbfeda7239f6 | Product name | 1 | 20190628 |
| 398aa563-bb78-fe0f-46a8-757c40ef28bf | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-7216-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1024-f424-e053-dadaa90a57ce | Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-7216-3 | cephalexin | 40 in 1 BOTTLE | CAPSULE | 40 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CEPHALEXIN | ACTIVE INGREDIENT | OBN7UDS42Y | CEPHALEXIN CAPSULE [UNIT DOSE SERVICES] | 4 | |
| CEPHALEXIN ANHYDROUS | ACTIVE MOIETY | 5SFF1W6677 | CEPHALEXIN CAPSULE [UNIT DOSE SERVICES] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CEPHALEXIN CAPSULE [UNIT DOSE SERVICES] | 4 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | CEPHALEXIN CAPSULE [UNIT DOSE SERVICES] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CEPHALEXIN CAPSULE [UNIT DOSE SERVICES] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CEPHALEXIN CAPSULE [UNIT DOSE SERVICES] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CEPHALEXIN CAPSULE [UNIT DOSE SERVICES] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CEPHALEXIN CAPSULE [UNIT DOSE SERVICES] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEPHALEXIN CAPSULE [UNIT DOSE SERVICES] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-7216 | CEPHALEXIN CAPSULE [UNIT DOSE SERVICES] | 4 | Legacy NDC, 1 package rows | 20130506_a1f0118a-c13b-4f8b-b77c-a40de5fd1444.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309112 | cephalexin 250 MG Oral Capsule | PSN | a1f0118a-c13b-4f8b-b77c-a40de5fd1444 | 4 |
| 309112 | cephalexin 250 MG Oral Capsule | SCD | a1f0118a-c13b-4f8b-b77c-a40de5fd1444 | 4 |
| 309112 | cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule | SY | a1f0118a-c13b-4f8b-b77c-a40de5fd1444 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-7216-3 | 50436721603 | 40 in 1 BOTTLE | Historical |