Prescription drug · ANDA
Cephalexin NDC 76420-592
Cephalexin 500 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-592-10 | 76420059210 | 100 CAPSULE in 1 BOTTLE (76420-592-10)Marketed from Sep 1, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cephalexin
- Generic name (nonproprietary)
- cephalexin
- Active ingredients
- Cephalexin — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090836
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 76420-592_044738e8-2630-d820-e063-6394a90a9e68SPL ID 044738e8-2630-d820-e063-6394a90a9e68SPL set ID 8073f183-e11f-41af-8bd1-1505bc7e044bRxCUI 309112, 309114, 637173, 645617UNII OBN7UDS42Y
- Pharmacologic class
- Cephalosporin Antibacterial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476420059210followed by a unit qualifier and the quantityPackage 76420-0592-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection ( 1.1 ) Otitis media ( 1.2 ) Skin and skin structure infections ( 1.3 ) Bone infections (1.4) Genitourinary tract infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, Cephalexin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6) 1.1 Respiratory Tract Infections Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090836
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4434 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2864 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7026 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4465 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7027 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3059 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8854 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Sportpharm LLC | 85766-005 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8855 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3199 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8856 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3202 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5948 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1830 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1831 |
| Cephalexin | Cephalexin 750 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1833 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3291 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2273 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Proficient Rx LP | 71205-672 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3427 |
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