Prescription drug · ANDA
Cephalexin NDC 68788-8538
Cephalexin 500 mg/1 · Capsule · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8538-1 | 68788853801 | 12 CAPSULE in 1 BOTTLE (68788-8538-1)Marketed from Oct 19, 2023 | |
| 68788-8538-2 | 68788853802 | 20 CAPSULE in 1 BOTTLE (68788-8538-2)Marketed from Oct 19, 2023 | |
| 68788-8538-3 | 68788853803 | 30 CAPSULE in 1 BOTTLE (68788-8538-3)Marketed from Oct 19, 2023 | |
| 68788-8538-4 | 68788853804 | 40 CAPSULE in 1 BOTTLE (68788-8538-4)Marketed from Oct 19, 2023 | |
| 68788-8538-5 | 68788853805 | 6 CAPSULE in 1 BOTTLE (68788-8538-5)Marketed from Oct 19, 2023 | |
| 68788-8538-6 | 68788853806 | 60 CAPSULE in 1 BOTTLE (68788-8538-6)Marketed from Oct 19, 2023 | |
| 68788-8538-7 | 68788853807 | 21 CAPSULE in 1 BOTTLE (68788-8538-7)Marketed from Oct 19, 2023 | |
| 68788-8538-8 | 68788853808 | 28 CAPSULE in 1 BOTTLE (68788-8538-8)Marketed from Oct 19, 2023 | |
| 68788-8538-9 | 68788853809 | 14 CAPSULE in 1 BOTTLE (68788-8538-9)Marketed from Oct 19, 2023 |
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 68788-8538_cabeccb5-a7a9-4906-90f5-70af57054fa6SPL ID cabeccb5-a7a9-4906-90f5-70af57054fa6SPL set ID 52d8a080-eafc-46fe-82d9-6b69c6a3a38aRxCUI 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
N468788853801followed by a unit qualifier and the quantityPackage 68788-8538-01. 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)
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…
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 | 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 | ADVANCED RX PHARMACY OF TENNESSEE, LLC | 80425-0004 |
| 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 |
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