Prescription drug · ANDA
Ertapenem NDC 0409-3510
Ertapenem sodium 1 g/1 · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-3510-22 | 00409351022 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3510-22) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-3510-21)Marketed from Oct 19, 2020 |
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)
- Ertapenem
- Generic name (nonproprietary)
- ertapenem
- Active ingredients
- Ertapenem sodium — 1 g/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208790
- Marketing start
- Listing expires
- Other FDA classes
- Carbapenems (Chemical structure)
- Identifiers
- Product ID 0409-3510_7dea65ba-ff7e-445b-972e-c972c3140d91SPL ID 7dea65ba-ff7e-445b-972e-c972c3140d91SPL set ID 178a0356-4f6c-47fb-9913-f325a3c72f7bRxCUI 1734683UNII 2T90KE67L0
- Pharmacologic class
- Penem 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
N400409351022followed by a unit qualifier and the quantityPackage 00409-3510-22. 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)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for Injection and other antibacterial drugs, Ertapenem for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment Ertapenem for Injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with the fo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208790
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 |
|---|---|---|---|---|
| ertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA, Inc. | 0143-9398 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-823 |
| ertapenem | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-820 |