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 | 6787705840167877058401 | 100 CAPSULE in 1 BOTTLE (67877-584-01)Marketed from Oct 12, 2018 | |
| 67877-584-05 | 6787705840567877058405 | 500 CAPSULE in 1 BOTTLE (67877-584-05)Marketed from Oct 12, 2018 | |
| 67877-584-33 | 6787705843367877058433 | 10 BLISTER PACK in 1 CARTON (67877-584-33) / 10 CAPSULE in 1 BLISTER PACKMarketed from Nov 26, 2020 | |
| 67877-584-50 | 6787705845067877058450 | 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, LLCNDC labeler code 67877
- 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.
About NDC 67877-584
- What is NDC 67877-584?
- 67877-584 is the product NDC for Cefixime, Cefixime 400 mg/1 capsule, listed with the FDA by Ascend Laboratories, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cefixime.
- What is the active ingredient?
- Cefixime.
- Who is the labeler?
- Ascend Laboratories, LLC, NDC labeler code 67877. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cefixime?
- 10 other product NDCs are listed under this name. See all Cefixime NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefixime products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4759 | 70518-4759-00 |
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-647 | 59651-0647-1059651-0647-50 |
| Cefixime | Cefixime 400 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-430 | 64980-0430-01 |
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3221 | 70518-3221-0270518-3221-04 |
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-423 | 68180-0423-0868180-0423-11 |
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2749 | 70518-2749-0270518-2749-05 |
| Cefixime | Cefixime 100 mg/5mL | Powder, For suspensionOral | Lupin Pharmaceuticals, Inc. | 68180-405 | 68180-0405-01 |
| Cefixime | Cefixime 200 mg/5mL | Powder, For suspensionOral | Lupin Pharmaceuticals, Inc. | 68180-407 | 68180-0407-0368180-0407-04 |
| Cefixime | Cefixime 100 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-751 | 65862-0751-0165862-0751-50 |
| Cefixime | Cefixime 200 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-752 | 65862-0752-5065862-0752-75 |
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 | Cefixime 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2749 |
| Cefixime 400 mgcefixime | Cefixime 400 mg/1 | CapsuleOral | Health Department, Oklahoma State | 83112-400 |