Prescription drug · ANDA
Cephalexin NDC 59651-728
Cephalexin 750 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-728-20 | 59651072820 | 20 CAPSULE in 1 BOTTLE (59651-728-20)Marketed from Dec 6, 2023 | |
| 59651-728-50 | 59651072850 | 50 CAPSULE in 1 BOTTLE (59651-728-50)Marketed from Dec 6, 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 — 750 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- 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 59651-728_e52db116-14f2-437d-8097-0150193d4655SPL ID e52db116-14f2-437d-8097-0150193d4655SPL set ID f957ea27-2906-40c7-ac03-eb2f742473a0RxCUI 637173UNII 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
N459651072820followed by a unit qualifier and the quantityPackage 59651-0728-20. 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 capsules are 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 capsules and other antibacterial drugs, cephalexin capsules 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 capsules are indicated for the treatment of respirato…
Excerpt only. Read the full label for complete information.
About NDC 59651-728
- What is NDC 59651-728?
- 59651-728 is the product NDC for Cephalexin, Cephalexin 750 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 2 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 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 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 | 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 | Aurobindo Pharma Limited | 65862-019 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2976 |
| 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 | NuCare Pharmaceuticals, Inc. | 68071-3740 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Cronus Pharma LLC | 69043-008 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2607 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0079 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7621 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0080 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Proficient Rx LP | 82804-106 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0081 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3532 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-710 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3538 |
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