Cephalexin
- Product NDC
- 21695-317
- 11-digit product format
- 216950317
- Labeler code
- 21695
- Product ID
- 21695-317_8bae9b61-3264-4cba-ad32-dfdec9259af3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cephalexin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA065253
- Marketing category
- ANDA
- Marketing start
- 2005-11-16
- Marketing end
- 0000-00-00
- Substance
- CEPHALEXIN
- Active strength
- 500 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 21695-317-12 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4734-48b1-e053-8cdaa90a720a | Cephalexin Capsules, USP |
| 21695-317-14 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4734-48b1-e053-8cdaa90a720a | Cephalexin Capsules, USP |
| 21695-317-20 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4734-48b1-e053-8cdaa90a720a | Cephalexin Capsules, USP |
| 21695-317-28 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4734-48b1-e053-8cdaa90a720a | Cephalexin Capsules, USP |
| 21695-317-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4734-48b1-e053-8cdaa90a720a | Cephalexin Capsules, USP |
| 21695-317-40 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4734-48b1-e053-8cdaa90a720a | Cephalexin Capsules, USP |
| 21695-317-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4734-48b1-e053-8cdaa90a720a | Cephalexin Capsules, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-317-12 | Cephalexin | 12 in 1 BOTTLE | CAPSULE | 12 | 1 | |
| 21695-317-14 | Cephalexin | 14 in 1 BOTTLE | CAPSULE | 14 | 1 | |
| 21695-317-20 | Cephalexin | 20 in 1 BOTTLE | CAPSULE | 20 | 1 | |
| 21695-317-28 | Cephalexin | 28 in 1 BOTTLE | CAPSULE | 28 | 1 | |
| 21695-317-30 | Cephalexin | 30 in 1 BOTTLE | CAPSULE | 30 | 1 | |
| 21695-317-40 | Cephalexin | 40 in 1 BOTTLE | CAPSULE | 40 | 1 | |
| 21695-317-60 | Cephalexin | 60 in 1 BOTTLE | CAPSULE | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-317-12 | EA - Each | 21695-317 | 30ce6119-737c-46de-9182-b166b3f32274 | 1 | 2012-07-24 |
| 21695-317-14 | EA - Each | 21695-317 | b50d0b0d-98d6-4792-9144-e203e01b29af | 1 | 2012-07-24 |
| 21695-317-20 | EA - Each | 21695-317 | 8b7be4df-478c-4e6e-ad59-b0eca2b305ef | 1 | 2012-07-24 |
| 21695-317-28 | EA - Each | 21695-317 | b5423adb-57df-46ca-8d77-7e1f4eba2a46 | 1 | 2012-07-24 |
| 21695-317-30 | EA - Each | 21695-317 | 9b623e77-db35-4707-96fe-e703bb31a9e8 | 1 | 2012-07-24 |
| 21695-317-40 | EA - Each | 21695-317 | da4d1280-4c5b-4da4-a07e-7e20ca68a8a5 | 1 | 2012-07-24 |
| 21695-317-60 | EA - Each | 21695-317 | df622f0e-5787-441d-baf5-df34b4a88c6b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Cephalexin | ACTIVE INGREDIENT | OBN7UDS42Y | CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| Cephalexin | ACTIVE MOIETY | OBN7UDS42Y | CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| Sodium Lauryl Sulfate | INACTIVE INGREDIENT | 368GB5141J | CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | CEPHALEXIN CAPSULE [REBEL DISTRIBUTORS CORP.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309112 | cephalexin 250 MG Oral Capsule | PSN | 12cdaf8c-06d1-45f2-b008-2ec33791bbe9 | 1 |
| 309114 | cephalexin 500 MG Oral Capsule | PSN | 12cdaf8c-06d1-45f2-b008-2ec33791bbe9 | 1 |
| 309112 | cephalexin 250 MG Oral Capsule | SCD | 12cdaf8c-06d1-45f2-b008-2ec33791bbe9 | 1 |
| 309114 | cephalexin 500 MG Oral Capsule | SCD | 12cdaf8c-06d1-45f2-b008-2ec33791bbe9 | 1 |
| 309114 | cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule | SY | 12cdaf8c-06d1-45f2-b008-2ec33791bbe9 | 1 |
| 309112 | cephalexin (as cephalexin monohydrate) 250 MG Oral Capsule | SY | 12cdaf8c-06d1-45f2-b008-2ec33791bbe9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-317-12 | 21695031712 | 12 in 1 BOTTLE | Historical |
| 21695-317-14 | 21695031714 | 14 in 1 BOTTLE | Historical |
| 21695-317-20 | 21695031720 | 20 in 1 BOTTLE | Historical |
| 21695-317-28 | 21695031728 | 28 in 1 BOTTLE | Historical |
| 21695-317-30 | 21695031730 | 30 in 1 BOTTLE | Historical |
| 21695-317-40 | 21695031740 | 40 in 1 BOTTLE | Historical |
| 21695-317-60 | 21695031760 | 60 in 1 BOTTLE | Historical |