Cephalexin
- Product NDC
- 43063-634
- 11-digit product format
- 430630634
- Labeler code
- 43063
- Product ID
- 43063-634_4139d250-e4e0-872f-e063-6394a90aabd6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cephalexin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA090836
- Marketing category
- ANDA
- Marketing start
- 2011-01-19
- Substance
- CEPHALEXIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cephalexin
- Listing expiration
- 2026-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-634-28 | Cephalexin | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | | 32 |
| 43063-634-40 | Cephalexin | 40 in 1 BOTTLE, PLASTIC | CAPSULE | 40 | | 32 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CEPHALEXIN | ACTIVE INGREDIENT | OBN7UDS42Y | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| CEPHALEXIN ANHYDROUS | ACTIVE MOIETY | 5SFF1W6677 | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEPHALEXIN (CEPHALEXIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 22 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-634 | CEPHALEXIN CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 31 | Current NDC, Legacy NDC, 2 package rows | 20240314_3dc725a0-6e4b-45c6-9569-34ef65455845.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 |
|---|
| 43063-634-28 | 43063063428 | 28 CAPSULE in 1 BOTTLE, PLASTIC (43063-634-28) | 28 capsule | 2024-03-12 | | No | No | Historical |
| 43063-634-40 | 43063063440 | 40 CAPSULE in 1 BOTTLE, PLASTIC (43063-634-40) | 40 capsule | 2015-11-02 | 0000-00-00 | No | No | Current |