Prescription drug · ANDA
Ertapenem (Ertapenem sodium) NDC 63323-823
Ertapenem sodium 1 g/1 · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-823-20 | 6332308232063323082320 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-823-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (63323-823-01)Marketed from Oct 10, 2019 |
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 sodium
- Active ingredients
- Ertapenem sodium — 1 g/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- 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 63323-823_8a08dc4b-9129-4b04-b586-19ca10abeafbSPL ID 8a08dc4b-9129-4b04-b586-19ca10abeafbSPL set ID 666c9f33-ea9e-4667-b8bd-f8b1b6b6be51RxCUI 1734683UNII 2T90KE67L0UPC 0363323823016
- 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
N463323082320followed by a unit qualifier and the quantityPackage 63323-0823-20. 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 of surgic…
Excerpt only. Read the full label for complete information.
About NDC 63323-823
- What is NDC 63323-823?
- 63323-823 is the product NDC for Ertapenem (ertapenem sodium), Ertapenem sodium 1 g/1 injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ertapenem (Ertapenem Sodium).
- What is the active ingredient?
- Ertapenem sodium.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ertapenem?
- 13 other product NDCs are listed under this name. See all Ertapenem NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ertapenem products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/20mL | InjectionIntramuscular, Intravenous | Apotex Corp | 60505-4956 | 60505-4956-00 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-199 | 25021-0199-20 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0143-9429 | 00143-9429-10 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Qilu Antibiotics Pharmaceutical Co., Ltd. | 51810-504 | 51810-0504-02 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Fosun Pharma USA Inc | 72266-159 | 72266-0159-0572266-0159-10 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Gland Pharma Limited | 68083-351 | 68083-0351-10 |
| Ertapenem | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Hospira, Inc. | 0409-3510 | 00409-3510-22 |
| ertapenem | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-820 | 44567-0820-10 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/20mL | InjectionIntramuscular, Intravenous | BluePoint Laboratories | 68001-408 | 68001-0408-31 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/20mL | InjectionIntramuscular, Intravenous | Apotex Corp | 60505-6196 | 60505-6196-04 |
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 | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Hospira, Inc. | 0409-3510 |
| ertapenem | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | WG Critical Care, LLC | 44567-820 |
| ertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA, Inc. | 0143-9398 |