Prescription drug · ANDA
Meropenem NDC 51810-503
Meropenem 1 g/30mL · Injection · Intravenous · Qilu Antibiotics Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51810-503-02 | 51810050302 | 10 VIAL in 1 CARTON (51810-503-02) / 30 mL in 1 VIAL (51810-503-01)Marketed from Dec 30, 2024 |
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)
- Meropenem
- Generic name (nonproprietary)
- meropenem
- Active ingredients
- Meropenem — 1 g/30mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216424
- Marketing start
- Listing expires
- Other FDA classes
- Carbapenems (Chemical structure)
- Identifiers
- Product ID 51810-503_787e8e01-2098-46ef-838c-1f7170c37630SPL ID 787e8e01-2098-46ef-838c-1f7170c37630SPL set ID 1f9591ed-3a6c-422e-b1be-7b3e4fe5bf3cRxCUI 1722934, 1722939UNII FV9J3JU8B1UPC 0351810503015, 0351810502018
- 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
N451810050302followed by a unit qualifier and the quantityPackage 51810-0503-02. 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)
Meropenen for injection 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 meropenen for injection and other antibacterial drugs, meropenen for injection 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 and Skin Struc…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216424
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 500 mg/20mL | InjectionIntravenous | Qilu Antibiotics Pharmaceutical Co., Ltd. | 51810-502 |
| Meropenem | Meropenem 500 mg/20mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9430 |
| Meropenem | Meropenem 1 g/30mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9431 |
| Meropenem | Meropenem 500 mg/20mL | Injection, Powder, For solutionIntravenous | Sagent Pharmaceuticals | 25021-160 |
| Meropenem | Meropenem 1 g/30mL | Injection, Powder, For solutionIntravenous | Sagent Pharmaceuticals | 25021-161 |