Prescription drug · ANDA
Ertapenem Sodium (ertapenem) NDC 16714-889
Ertapenem sodium 1 g/1 · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-889-10 | 16714088910 | 10 VIAL, SINGLE-DOSE in 1 CARTON (16714-889-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (16714-889-01)Marketed from Jul 13, 2021 |
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 Sodium
- Generic name (nonproprietary)
- ertapenem
- Active ingredients
- Ertapenem sodium — 1 g/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular, Intravenous
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212040
- Marketing start
- Listing expires
- Other FDA classes
- Carbapenems (Chemical structure)
- Identifiers
- Product ID 16714-889_b1a0c90d-c014-6561-5ab3-07e98e9fdfeaSPL ID b1a0c90d-c014-6561-5ab3-07e98e9fdfeaSPL set ID 2398d418-6efc-b4d2-3265-936001df9b8bRxCUI 1734683UNII 2T90KE67L0UPC 0316714889016
- 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
N416714088910followed by a unit qualifier and the quantityPackage 16714-0889-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 212040
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 Sodiumertapenem | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Dr.Reddys Laboratories Inc., | 43598-901 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Gland Pharma Limited | 68083-351 |
| Ertapenemertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Fosun Pharma USA Inc | 72266-159 |