Prescription drug · NDA
Teflaro (Ceftaroline fosamil) NDC 0456-0400
Ceftaroline fosamil 400 mg/20mL · Powder, For solution · Intravenous · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0456-0400-10 | 00456040010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)Marketed from Oct 29, 2010 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Teflaro
- Generic name (nonproprietary)
- ceftaroline fosamil
- Active ingredients
- Ceftaroline fosamil — 400 mg/20mL
- Dosage form
- Powder, For solution
- Route
- Intravenous
- Labeler
- Allergan, Inc.NDC labeler code 0456
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 200327
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 0456-0400_80f8b668-c4e3-472a-acfa-edececd8b7e4SPL ID 80f8b668-c4e3-472a-acfa-edececd8b7e4SPL set ID 3ecde48b-75a2-4beb-9999-369f3f61bb8aRxCUI 1040008, 1040012, 1040014, 1040016UNII 7P6FQA5D21UPC 0304560400103
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400456040010followed by a unit qualifier and the quantityPackage 00456-0400-10. 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)
1. INDICATIONS AND USAGE Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) ( 1.1 ) Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used only to treat or prevent infections that are proven or strongly suspected to be c…
Excerpt only. Read the full label for complete information.
About NDC 0456-0400
- What is NDC 0456-0400?
- 0456-0400 is the product NDC for Teflaro (ceftaroline fosamil), Ceftaroline fosamil 400 mg/20mL powder, for solution, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Teflaro (Ceftaroline fosamil).
- What is the active ingredient?
- Ceftaroline fosamil.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0456. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Teflaro?
- 1 other product NDC are listed under this name. See all Teflaro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Teflaro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Teflaroceftaroline fosamil | Ceftaroline fosamil 600 mg/20mL | Powder, For solutionIntravenous | Allergan, Inc. | 0456-0600 | 00456-0600-10 |
Other NDCs under NDA 200327
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 |
|---|---|---|---|---|
| Teflaroceftaroline fosamil | Ceftaroline fosamil 600 mg/20mL | Powder, For solutionIntravenous | Allergan, Inc. | 0456-0600 |