Prescription drug · ANDA
Meropenem NDC 68001-323
Meropenem 500 mg/20mL · Injection, Powder, For solution · Intravenous · BluePoint Laboratories
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Meropenem
- Generic name (nonproprietary)
- meropenem
- Active ingredients
- Meropenem — 500 mg/20mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- BluePoint LaboratoriesNDC labeler code 68001
- 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 68001-323_45bbbbfc-a4d7-c7ed-e063-6294a90aca41SPL ID 45bbbbfc-a4d7-c7ed-e063-6294a90aca41SPL set ID ca5f501c-6520-4d09-aae2-4f5db74d468fRxCUI 1722934, 1722939UNII FV9J3JU8B1UPC 0368001323291, 0368001324588
- 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.
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.
About NDC 68001-323
- What is NDC 68001-323?
- 68001-323 is the product NDC for Meropenem, Meropenem 500 mg/20mL injection, powder, for solution, listed with the FDA by BluePoint Laboratories.
- What drug is associated with this NDC?
- Meropenem.
- What is the active ingredient?
- Meropenem.
- Who is the labeler?
- BluePoint Laboratories, NDC labeler code 68001. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Meropenem?
- 46 other product NDCs are listed under this name. See all Meropenem NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Meropenem products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Meropenem | Meropenem 500 mg/10mL | Injection, Powder, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9485 | 00143-9485-10 |
| Meropenem | Meropenem 1 g/20mL | Injection, Powder, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9486 | 00143-9486-10 |
| Meropenem | Meropenem 500 mg/20mL | Injection, Powder, For solutionIntravenous | Sagent Pharmaceuticals | 25021-160 | 25021-0160-20 |
| Meropenem | Meropenem 1 g/30mL | Injection, Powder, For solutionIntravenous | Sagent Pharmaceuticals | 25021-161 | 25021-0161-30 |
| Meropenem | Meropenem 1 g/20mL | InjectionIntravenous | Civica, Inc. | 72572-410 | 72572-0410-10 |
| Meropenem | Meropenem 500 mg/20mL | InjectionIntravenous | Civica, Inc. | 72572-412 | 72572-0412-10 |
| Meropenem | Meropenem anhydrous 2 g/1 | InjectionIntravenous | Mylan Institutional LLC | 72078-081 | 72078-0081-06 |
| Meropenem | Meropenem anhydrous 2 g/1 | InjectionIntravenous | BROOKS STERISCIENCE LIMITED | 81962-002 | 81962-0002-08 |
| Meropenem | Meropenem 500 mg/20mL | InjectionIntravenous | Qilu Antibiotics Pharmaceutical Co., Ltd. | 51810-502 | 51810-0502-02 |
| Meropenem | Meropenem 1 g/30mL | InjectionIntravenous | Qilu Antibiotics Pharmaceutical Co., Ltd. | 51810-503 | 51810-0503-02 |
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 | Amneal Pharmaceuticals LLC | 70121-1454 |
| Meropenem | Meropenem 1 g/30mL | Injection, Powder, For solutionIntravenous | Amneal Pharmaceuticals LLC | 70121-1453 |