Cephalexin
- Product NDC
- 10544-082
- 11-digit product format
- 105440082
- Labeler code
- 10544
- Product ID
- 10544-082_134a8f8c-7fb1-4033-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cephalexin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA062713
- Marketing category
- ANDA
- Marketing start
- 2012-08-01
- Marketing end
- 0000-00-00
- Substance
- CEPHALEXIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
- 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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|---|---|---|
| 10544-082-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2097-f424-e053-dadaa90a57ce | CEPHALEXIN CAPSULES, USP |
| 10544-082-14 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2097-f424-e053-dadaa90a57ce | CEPHALEXIN CAPSULES, USP |
| 10544-082-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2097-f424-e053-dadaa90a57ce | CEPHALEXIN CAPSULES, USP |
| 10544-082-21 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2097-f424-e053-dadaa90a57ce | CEPHALEXIN CAPSULES, USP |
| 10544-082-28 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2097-f424-e053-dadaa90a57ce | CEPHALEXIN CAPSULES, USP |
| 10544-082-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2097-f424-e053-dadaa90a57ce | CEPHALEXIN CAPSULES, USP |
| 10544-082-40 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2097-f424-e053-dadaa90a57ce | CEPHALEXIN CAPSULES, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10544-082-10 | Cephalexin | 10 in 1 BOTTLE | CAPSULE | 10 | 3 | |
| 10544-082-14 | Cephalexin | 14 in 1 BOTTLE | CAPSULE | 14 | 3 | |
| 10544-082-20 | Cephalexin | 20 in 1 BOTTLE | CAPSULE | 20 | 3 | |
| 10544-082-21 | Cephalexin | 21 in 1 BOTTLE | CAPSULE | 21 | 3 | |
| 10544-082-28 | Cephalexin | 28 in 1 BOTTLE | CAPSULE | 28 | 3 | |
| 10544-082-30 | Cephalexin | 30 in 1 BOTTLE | CAPSULE | 30 | 3 | |
| 10544-082-40 | Cephalexin | 40 in 1 BOTTLE | CAPSULE | 40 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10544-082-10 | EA - Each | 10544-082 | fc81ab1d-da14-4249-b6d7-48ab3c5f5679 | 1 | 2015-04-03 |
| 10544-082-14 | EA - Each | 10544-082 | 530ff92f-8323-4be0-b1e2-e57e8d1a0cc3 | 1 | 2015-04-03 |
| 10544-082-20 | EA - Each | 10544-082 | 3d86bcbd-708f-4af9-b566-b3afa36244fa | 1 | 2015-03-03 |
| 10544-082-21 | EA - Each | 10544-082 | f9ce03b5-19e2-4fb0-883c-247b0559d6b6 | 1 | 2015-04-03 |
| 10544-082-28 | EA - Each | 10544-082 | 6b12f0fc-6f14-4b41-bf7a-21513d2fab4d | 1 | 2015-04-03 |
| 10544-082-30 | EA - Each | 10544-082 | 614826cb-ae90-4dbd-802b-36afcbf4c9b4 | 1 | 2015-03-03 |
| 10544-082-40 | EA - Each | 10544-082 | 95bef275-ba78-4af9-80af-77221a5c5ef5 | 1 | 2015-03-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CEPHALEXIN | ACTIVE INGREDIENT | OBN7UDS42Y | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| CEPHALEXIN ANHYDROUS | ACTIVE MOIETY | 5SFF1W6677 | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309114 | cephalexin 500 MG Oral Capsule | PSN | 1b187be2-dbe3-49e9-a37b-573bf938966c | 3 |
| 309114 | cephalexin 500 MG Oral Capsule | SCD | 1b187be2-dbe3-49e9-a37b-573bf938966c | 3 |
| 309114 | cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule | SY | 1b187be2-dbe3-49e9-a37b-573bf938966c | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10544-082-10 | 10544008210 | 10 in 1 BOTTLE | Historical |
| 10544-082-14 | 10544008214 | 14 in 1 BOTTLE | Historical |
| 10544-082-20 | 10544008220 | 20 in 1 BOTTLE | Historical |
| 10544-082-21 | 10544008221 | 21 in 1 BOTTLE | Historical |
| 10544-082-28 | 10544008228 | 28 in 1 BOTTLE | Historical |
| 10544-082-30 | 10544008230 | 30 in 1 BOTTLE | Historical |
| 10544-082-40 | 10544008240 | 40 in 1 BOTTLE | Historical |