cephalexin
- Product NDC
- 10544-057
- 11-digit product format
- 105440057
- Labeler code
- 10544
- Product ID
- 10544-057_11f3b578-7076-4b9c-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cephalexin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA062791
- Marketing category
- ANDA
- Marketing start
- 2012-06-27
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 10544-057-14 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5a94-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. |
| 10544-057-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5a94-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. |
| 10544-057-21 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5a94-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. |
| 10544-057-28 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5a94-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. |
| 10544-057-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5a94-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. |
| 10544-057-40 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5a94-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. |
| 10544-057-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5a94-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#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CEPHALEXIN | ACTIVE INGREDIENT | OBN7UDS42Y | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| CEPHALEXIN ANHYDROUS | ACTIVE MOIETY | 5SFF1W6677 | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-057 | CEPHALEXIN CAPSULE [BLENHEIM PHARMACAL, INC.] | 5 | Legacy NDC, 7 package rows | 20150323_9fe6fa13-c357-4c6b-83f8-33f74ce0ebdc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-057-14 | 10544005714 | 14 in 1 BOTTLE | Historical |
| 10544-057-20 | 10544005720 | 20 in 1 BOTTLE | Historical |
| 10544-057-21 | 10544005721 | 21 in 1 BOTTLE | Historical |
| 10544-057-28 | 10544005728 | 28 in 1 BOTTLE | Historical |
| 10544-057-30 | 10544005730 | 30 in 1 BOTTLE | Historical |
| 10544-057-40 | 10544005740 | 40 in 1 BOTTLE | Historical |
| 10544-057-60 | 10544005760 | 60 in 1 BOTTLE | Historical |