Cephalexin
- Product NDC
- 76420-831
- 11-digit product format
- 764200831
- Labeler code
- 76420
- Product ID
- 76420-831_247cf995-f553-60a9-e063-6394a90ad8d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cephalexin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc
- Application
- ANDA065229
- Marketing category
- ANDA
- Marketing start
- 2023-09-07
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| OBN7UDS42Y | CEPHALEXIN | 23325-78-2 | CEPHALEXIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-831-10 | 76420083110 | 10 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-10) | 10 capsule | 2024-07-17 | No | No | Historical |
| 76420-831-30 | 76420083130 | 30 CAPSULE in 1 BLISTER PACK (76420-831-30) | 30 capsule | 2024-07-17 | No | No | Historical |
| 76420-831-40 | 76420083140 | 40 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-40) | 40 capsule | 2024-07-17 | No | No | Historical |
| 76420-831-42 | 76420083142 | 42 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-42) | 42 capsule | 2024-07-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Cephalexin | Asclemed USA, Inc | ASCLEMED USA INC. DBA ENOVACHEM | 2024-07-17 | HUMAN PRESCRIPTION DRUG LABEL | 1 |