Prescription drug · ANDA
Cephalexin NDC 68071-4406
Cephalexin 500 mg/1 · Capsule · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4406-4 | 68071440604 | 14 CAPSULE in 1 BOTTLE (68071-4406-4)Marketed from Apr 26, 2018 | |
| 68071-4406-7 | 68071440607 | 40 CAPSULE in 1 BOTTLE (68071-4406-7)Marketed from Apr 26, 2018 |
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
- NuCare Pharmaceuticals,Inc.
- 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 68071-4406_1a8b85ac-ef99-e207-e063-6394a90a80f1SPL ID 1a8b85ac-ef99-e207-e063-6394a90a80f1SPL set ID 6ac71dc8-7f86-60c5-e053-2a91aa0a2a7eRxCUI 309114UNII OBN7UDS42YUPC 0368071440676
- 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
N468071440604followed by a unit qualifier and the quantityPackage 68071-4406-04. 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 USP is 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 USP and other antibacterial drugs, cephalexin capsules USP 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 USP are indicated for the treatme…
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 | 80425-0005 |
| 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 |