Prescription drug · ANDA
Meropenem NDC 70121-1454
Meropenem 500 mg/20mL · Injection, Powder, For solution · Intravenous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-1454-7 | 70121145407 | 10 VIAL, GLASS in 1 CARTON (70121-1454-7) / 20 mL in 1 VIAL, GLASS (70121-1454-1)Marketed from May 9, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Meropenem
- Generic name (nonproprietary)
- meropenem
- Active ingredients
- Meropenem — 500 mg/20mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205883
- Marketing start
- Listing expires
- Other FDA classes
- Carbapenems (Chemical structure)
- Identifiers
- Product ID 70121-1454_c346bc7b-a9e5-4669-bbf0-ea71912fd0fbSPL ID c346bc7b-a9e5-4669-bbf0-ea71912fd0fbSPL set ID a456013b-b20e-4b29-b2f9-06f18f1ea6bdRxCUI 1722934, 1722939UNII FV9J3JU8B1
- 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
N470121145407followed by a unit qualifier and the quantityPackage 70121-1454-07. 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)
Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1) Complicated intra-abdominal infections (adult and pediatric patients). (1.2) Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3) To reduce the development of drug-resistant bacteria and maintain the effectiveness of meropenem for injection (I.V.) and other antibacterial drugs, meropenem for injection (I.V.) should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.1 Complicated Skin an…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205883
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 |
|---|---|---|---|---|
| Meropenem | Meropenem 1 g/30mL | Injection, Powder, For solutionIntravenous | BluePoint Laboratories | 68001-324 |
| Meropenem | Meropenem 500 mg/20mL | Injection, Powder, For solutionIntravenous | BluePoint Laboratories | 68001-323 |
| Meropenem | Meropenem 1 g/30mL | Injection, Powder, For solutionIntravenous | Amneal Pharmaceuticals LLC | 70121-1453 |