Prescription drug · ANDA
Cefuroxime axetil NDC 67877-216
Cefuroxime axetil 500 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-216-01 | 6787702160167877021601 | 100 TABLET, FILM COATED in 1 BOTTLE (67877-216-01)Marketed from Dec 1, 2010 | |
| 67877-216-20 | 6787702162067877021620 | 20 TABLET, FILM COATED in 1 BOTTLE (67877-216-20)Marketed from Dec 1, 2010 | |
| 67877-216-60 | 6787702166067877021660 | 60 TABLET, FILM COATED in 1 BOTTLE (67877-216-60)Marketed from Dec 1, 2010 | |
| 67877-216-84 | 6787702168467877021684 | 30 BLISTER PACK in 1 CARTON (67877-216-84) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 1, 2010 |
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)
- Cefuroxime axetil
- Generic name (nonproprietary)
- cefuroxime axetil
- Active ingredients
- Cefuroxime axetil — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065496
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 67877-216_7c9fa966-9491-40a8-a57b-6f60dbf7bb55SPL ID 7c9fa966-9491-40a8-a57b-6f60dbf7bb55SPL set ID dd11e4b9-7730-4d3a-81ca-16f15de09759RxCUI 309097, 309098UNII Z49QDT0J8ZUPC 0367877216607
- 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
N467877021601followed by a unit qualifier and the quantityPackage 67877-0216-01. 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)
Cefuroxime axetil tablet is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1) Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1 ) Acute bacterial otitis media (pediatric patients) ( 1.2 ) Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3 ) Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) ( 1.4 ) Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) ( 1.5 ) Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) ( 1.6 ) Uncomplicated gonorrhea (adults a…
Excerpt only. Read the full label for complete information.
About NDC 67877-216
- What is NDC 67877-216?
- 67877-216 is the product NDC for Cefuroxime axetil, Cefuroxime axetil 500 mg/1 tablet, film coated, 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?
- Cefuroxime axetil.
- What is the active ingredient?
- Cefuroxime axetil.
- 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 Cefuroxime axetil?
- 40 other product NDCs are listed under this name. See all Cefuroxime axetil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefuroxime axetil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0571 | 80425-0571-0180425-0571-02 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7542 | 00904-7542-10 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8905 | 68788-8905-02 |
| Cefuroxime Axetil | Cefuroxime axetil 250 mg/1 | TabletOral | Coupler LLC | 67046-1307 | 67046-1307-03 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | TabletOral | Coupler LLC | 67046-1081 | 67046-1081-03 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-283 | 60687-0283-94 |
| Cefuroxime Axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3215 | 70518-3215-04 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-272 | 60687-0272-94 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-656 | 43063-0656-1443063-0656-20 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-657 | 43063-0657-2043063-0657-60 |
Other NDCs under ANDA 065496
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 |
|---|---|---|---|---|
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3975 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-333 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-272 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-334 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-283 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-035 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0571 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4947 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-1637 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7542 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-215 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-991 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2159 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2157 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2158 |
| Cefuroxime axetil | Cefuroxime axetil 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2168 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-656 |
| Cefuroxime axetil | Cefuroxime axetil 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-657 |