Prescription drug · ANDA
Cephalexin NDC 80425-0005
Cephalexin 500 mg/1 · Capsule · Oral · ADVANCED RX PHARMACY OF TENNESSEE, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0005-1 | 80425000501 | 28 CAPSULE in 1 BOTTLE (80425-0005-1)Marketed from Jan 11, 2006 | |
| 80425-0005-2 | 80425000502 | 40 CAPSULE in 1 BOTTLE (80425-0005-2)Marketed from Jan 11, 2006 | |
| 80425-0005-3 | 80425000503 | 6 CAPSULE in 1 BOTTLE (80425-0005-3)Marketed from Jan 18, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065229
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 80425-0005_0f3ed48b-be43-1ecb-e063-6294a90a6eb0SPL ID 0f3ed48b-be43-1ecb-e063-6294a90a6eb0SPL set ID af10128f-021a-14b7-e053-2a95a90a4365RxCUI 309114UNII 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
N480425000501followed by a unit qualifier and the quantityPackage 80425-0005-01. 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)
1. Indications and Usage Section 1 INDICATIONS AND USAGE 1.1 Respiratory Tract Infections Cephalexin capsules USP are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media Cephalexin capsules USP are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. 1.3 Skin and Skin Structure Infections Cephalexin capsules USP are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-po…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065229
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 500 mg/1 | CapsuleOral | Sportpharm LLC | 85766-004 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4516 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-288 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-287 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3857 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-121 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-122 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-736 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | ADVANCED RX PHARMACY OF TENNESSEE, LLC | 80425-0006 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5241 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3448 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-052 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Proficient Rx LP | 63187-046 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Asclemed USA, Inc | 76420-831 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Coupler LLC | 67046-1245 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4406 |