Prescription drug · NDA AUTHORIZED GENERIC
Cefixime NDC 68180-423
Cefixime 400 mg/1 · Capsule · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-423-08 | 68180042308 | 50 CAPSULE in 1 BOTTLE (68180-423-08)Marketed from Oct 14, 2020 | |
| 68180-423-11 | 68180042311 | 1 BLISTER PACK in 1 CARTON (68180-423-11) / 10 CAPSULE in 1 BLISTER PACKMarketed from Oct 14, 2020 |
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)
- Cefixime
- Generic name (nonproprietary)
- cefixime
- Active ingredients
- Cefixime — 400 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 203195
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 68180-423_735f86f4-369c-4f5a-adbe-7dacea2e27b4SPL ID 735f86f4-369c-4f5a-adbe-7dacea2e27b4SPL set ID 6d68dbd9-7d75-4ff1-91db-79ff8ae879ecRxCUI 309058, 409823, 419849UNII 97I1C92E55UPC 0368180423089, 0368180407034, 0368180416081, 0368180416111
- 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
N468180042308followed by a unit qualifier and the quantityPackage 68180-0423-08. 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)
Cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections ( 1.1 ) Otitis Media ( 1.2 ) Pharyngitis and Tonsillitis ( 1.3 ) Acute Exacerbations of Chronic Bronchitis ( 1.4 ) Uncomplicated Gonorrhea (cervical/urethral) ( 1.5 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime for oral suspension and cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 203195
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 |
|---|---|---|---|---|
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3221 |