Prescription drug · ANDA
Ertapenem Sodium (Ertapenem) NDC 43598-901
Ertapenem sodium 1 g/1 · Injection, Powder, Lyophilized, For solution · Intramuscular, Intravenous · Dr.Reddys Laboratories Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-901-58 | 4359809015843598090158 | 10 VIAL, SINGLE-DOSE in 1 CARTON (43598-901-58) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (43598-901-11)Marketed from Apr 29, 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
- Dr.Reddys Laboratories Inc.,NDC labeler code 43598
- 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 43598-901_39078864-5998-878d-b70d-8f46a61bbf02SPL ID 39078864-5998-878d-b70d-8f46a61bbf02SPL set ID 32d9f095-ca39-7e22-6264-b54f2daaee57RxCUI 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
N443598090158followed by a unit qualifier and the quantityPackage 43598-0901-58. 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.
About NDC 43598-901
- What is NDC 43598-901?
- 43598-901 is the product NDC for Ertapenem Sodium (ertapenem), Ertapenem sodium 1 g/1 injection, powder, lyophilized, for solution, listed with the FDA by Dr.Reddys Laboratories Inc.,. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ertapenem Sodium (Ertapenem).
- What is the active ingredient?
- Ertapenem sodium.
- Who is the labeler?
- Dr.Reddys Laboratories Inc.,, NDC labeler code 43598. 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 Sodium?
- 2 other product NDCs are listed under this name. See all Ertapenem Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ertapenem Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ertapenem sodium | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA, Inc. | 0143-9398 | 00143-9398-10 |
| Ertapenem Sodiumertapenem | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | NorthStar RxLLC | 16714-889 | 16714-0889-10 |
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 |
|---|---|---|---|---|
| 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 |
| Ertapenem Sodiumertapenem | Ertapenem sodium 1 g/1 | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | NorthStar RxLLC | 16714-889 |