Prescription drug · ANDA
Cephalexin NDC 80425-0121
Cephalexin 500 mg/1 · Capsule · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0121-1 | 80425012101 | 28 CAPSULE in 1 BOTTLE (80425-0121-1)Marketed from Jan 19, 2011 | |
| 80425-0121-2 | 80425012102 | 40 CAPSULE in 1 BOTTLE (80425-0121-2)Marketed from Jan 19, 2011 | |
| 80425-0121-3 | 80425012103 | 30 CAPSULE in 1 BOTTLE (80425-0121-3)Marketed from Jan 19, 2011 | |
| 80425-0121-4 | 80425012104 | 20 CAPSULE in 1 BOTTLE (80425-0121-4)Marketed from Jan 19, 2011 | |
| 80425-0121-5 | 80425012105 | 14 CAPSULE in 1 BOTTLE (80425-0121-5)Marketed from Jan 19, 2011 | |
| 80425-0121-6 | 80425012106 | 5 CAPSULE in 1 BOTTLE (80425-0121-6)Marketed from Sep 15, 2023 | |
| 80425-0121-7 | 80425012107 | 6 CAPSULE in 1 BOTTLE (80425-0121-7)Marketed from Jan 17, 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
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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 80425-0121_0f2824d5-e8e8-b3d6-e063-6294a90a3379SPL ID 0f2824d5-e8e8-b3d6-e063-6294a90a3379SPL set ID b6ffe633-dd91-6d49-e053-2a95a90a5ac6RxCUI 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
N480425012101followed by a unit qualifier and the quantityPackage 80425-0121-01. 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 & USAGE 1.1 Respiratory Tract Infections Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media Cephalexin is 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 is 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.
About NDC 80425-0121
- What is NDC 80425-0121?
- 80425-0121 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cephalexin.
- What is the active ingredient?
- Cephalexin.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cephalexin?
- 185 other product NDCs are listed under this name. See all Cephalexin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cephalexin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4143 | 68788-4143-0168788-4143-0268788-4143-03+6 more |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4167 | 68788-4167-0268788-4167-0368788-4167-04+3 more |
| Cephalexin | Cephalexin 250 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 59651-323 | 59651-0323-0159651-0323-02 |
| Cephalexin | Cephalexin 125 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 59651-322 | 59651-0322-0159651-0322-02 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Coupler LLC | 67046-1245 | 67046-1245-03 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | AVKARE | 42291-006 | 42291-0006-50 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | AVKARE | 42291-007 | 42291-0007-50 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-095 | 82868-0095-1082868-0095-2082868-0095-21+2 more |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | REMEDYREPACK INC. | 70518-4511 | 70518-4511-00 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Coupler, LLC | 67046-1533 | 67046-1533-03 |
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 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9200 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9198 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-9199 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7336 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Proficient Rx LP | 71205-672 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7337 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3427 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | American Health Packaging | 60687-152 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3378 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | American Health Packaging | 60687-163 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-497 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Direct_Rx | 61919-606 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | DIRECT RX | 61919-606 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-536 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | AvPAK | 50268-151 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | AvPAK | 50268-152 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7223 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-592 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Sportpharm LLC | 85766-191 |
| Cephalexin | Cephalexin 333 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-593 |
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