Prescription drug · ANDA
Cefixime NDC 67877-584
Cefixime 400 mg/1 · Capsule · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-584-01 | 67877058401 | 100 CAPSULE in 1 BOTTLE (67877-584-01)Marketed from Oct 12, 2018 | |
| 67877-584-05 | 67877058405 | 500 CAPSULE in 1 BOTTLE (67877-584-05)Marketed from Oct 12, 2018 | |
| 67877-584-33 | 67877058433 | 10 BLISTER PACK in 1 CARTON (67877-584-33) / 10 CAPSULE in 1 BLISTER PACKMarketed from Nov 26, 2020 | |
| 67877-584-50 | 67877058450 | 50 CAPSULE in 1 BOTTLE (67877-584-50)Marketed from Oct 12, 2018 |
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
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210574
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 67877-584_30690cba-b831-45c1-b799-a013d6cfc2dbSPL ID 30690cba-b831-45c1-b799-a013d6cfc2dbSPL set ID 6f1df975-f825-4301-87da-d7eba56a6890RxCUI 409823UNII 97I1C92E55
- 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
N467877058401followed by a unit qualifier and the quantityPackage 67877-0584-01. 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)
Cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric six months and older with the following infections: Uncomplicated Urinary Tract Infections ( 1.1 ) Pharyngitis and Tonsillitis ( 1.3 ) Acute Exacerbations of Chronic Bronchitis ( 1.4 ) Uncomplicated Gonorrhea (cervical/urethral) ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 1.1 Uncomplicated Urinary Tract Infections Cefixime is indicated in the treatment of adults and pediatric patients six months…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210574
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 400 mgcefixime | Cefixime 400 mg/1 | CapsuleOral | Health Department, Oklahoma State | 83112-400 |
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2749 |