Prescription drug · ANDA
ertapenem NDC 44567-820
Ertapenem sodium 1 g/1 · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · WG Critical Care, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44567-820-10 | 44567082010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (44567-820-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (44567-820-01)Marketed from Jan 7, 2020 |
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)
- ertapenem
- Generic name (nonproprietary)
- ertapenem
- Active ingredients
- Ertapenem sodium — 1 g/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- WG Critical Care, LLC
- 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 44567-820_befbf704-5aae-474b-8457-c77b2ab7835eSPL ID befbf704-5aae-474b-8457-c77b2ab7835eSPL set ID cf3cfa6b-211c-452b-b18b-e462b21e6909RxCUI 1734683UNII 2T90KE67L0UPC 0344567820016
- 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
N444567082010followed by a unit qualifier and the quantityPackage 44567-0820-10. 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)
Ertapenem for Injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: • Complicated intra-abdominal infections. ( 1.1 ) • Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. ( 1.2 ) • Community-acquired pneumonia. ( 1.3 ) • Complicated urinary tract infections including pyelonephritis. ( 1.4 ) • Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections. ( 1.5 ) Ertapenem for Injection is indicated in adults for the prophylaxis…
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 |
| Ertapenem | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Hospira, Inc. | 0409-3510 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-823 |