Prescription drug · ANDA
Cephalexin NDC 80425-0004
Cephalexin 500 mg/1 · Capsule · Oral · ADVANCED RX PHARMACY OF TENNESSEE, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0004-1 | 80425000401 | 28 CAPSULE in 1 BOTTLE (80425-0004-1)Marketed from Sep 14, 2022 | |
| 80425-0004-2 | 80425000402 | 40 CAPSULE in 1 BOTTLE (80425-0004-2)Marketed from Sep 14, 2022 | |
| 80425-0004-3 | 80425000403 | 6 CAPSULE in 1 BOTTLE (80425-0004-3)Marketed from Jan 18, 2024 | |
| 80425-0004-4 | 80425000404 | 5 CAPSULE in 1 BOTTLE (80425-0004-4)Marketed from Jan 18, 2024 | |
| 80425-0004-5 | 80425000405 | 14 CAPSULE in 1 BOTTLE (80425-0004-5)Marketed from Jan 18, 2024 | |
| 80425-0004-6 | 80425000406 | 20 CAPSULE in 1 BOTTLE (80425-0004-6)Marketed from Jan 18, 2024 | |
| 80425-0004-7 | 80425000407 | 30 CAPSULE in 1 BOTTLE (80425-0004-7)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 065253
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 80425-0004_137a5de3-ab83-e2ab-e063-6294a90a6209SPL ID 137a5de3-ab83-e2ab-e063-6294a90a6209SPL set ID af49507d-254f-296d-e053-2a95a90ad263RxCUI 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
N480425000401followed by a unit qualifier and the quantityPackage 80425-0004-01. 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 1.1 Respiratory Tract Infections Cephalexin capsules 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 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 are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and S…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065253
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 | Bryant Ranch Prepack | 63629-4219 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3066 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | AMELLA PHARMA, LLC | 72287-310 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4250 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8538 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2685 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Coupler, LLC | 67046-1533 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3680 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2704 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-057 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-5740 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-5741 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-5742 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2976 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-019 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-018 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Cronus Pharma LLC | 69043-009 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Cronus Pharma LLC | 69043-008 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3740 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2607 |
Showing 20 of 30.