Prescription drug · ANDA
Cephalexin NDC 62135-480
Cephalexin 125 mg/5mL · Powder, For suspension · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-480-42 | 62135048042 | 100 mL in 1 BOTTLE (62135-480-42)Marketed from Feb 1, 2022 | |
| 62135-480-49 | 62135048049 | 200 mL in 1 BOTTLE (62135-480-49)Marketed from Feb 1, 2022 |
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 — 125 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065336
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 62135-480_459b5240-6bbf-1d2d-e063-6294a90aac45SPL ID 459b5240-6bbf-1d2d-e063-6294a90aac45SPL set ID 8a09bccd-1864-4dc3-9c31-6187d8e0fc99RxCUI 309110, 309113UNII OBN7UDS42YUPC 0362135480493, 0362135481421, 0362135481490, 0362135480424
- 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
N462135048042followed by a unit qualifier and the quantityPackage 62135-0480-42. 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 for oral suspension, USP 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 for oral suspension, USP and other antibacterial drugs, Cephalexin for oral suspension, USP 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 ind…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065336
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/5mL | Powder, For suspensionOral | Chartwell RX, LLC | 62135-481 |