Prescription drug · ANDA
Ertapenem NDC 55150-282
Ertapenem sodium 1 g/1 · Injection · Intramuscular, Intravenous · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-282-20 | 5515002822055150028220 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-20) / 1 INJECTION in 1 VIAL, SINGLE-DOSEMarketed from Jun 25, 2018 |
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
- Route
- Intramuscular, Intravenous
- Labeler
- Eugia US LLCNDC labeler code 55150
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209133
- Marketing start
- Listing expires
- Other FDA classes
- Carbapenems (Chemical structure)
- Identifiers
- Product ID 55150-282_250abb8f-6547-4f69-94c3-87917dc34240SPL ID 250abb8f-6547-4f69-94c3-87917dc34240SPL set ID f725a68c-31a2-482a-9744-19adc47506b5RxCUI 1734683UNII 2T90KE67L0UPC 0355150282203
- 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
N455150028220followed by a unit qualifier and the quantityPackage 55150-0282-20. 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 surgical site in…
Excerpt only. Read the full label for complete information.
About NDC 55150-282
- What is NDC 55150-282?
- 55150-282 is the product NDC for Ertapenem, Ertapenem sodium 1 g/1 injection, listed with the FDA by Eugia US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ertapenem.
- What is the active ingredient?
- Ertapenem sodium.
- Who is the labeler?
- Eugia US LLC, NDC labeler code 55150. 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/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-823 | 63323-0823-20 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/20mL | InjectionIntramuscular, Intravenous | BluePoint Laboratories | 68001-408 | 68001-0408-31 |