Prescription drug · ANDA
Meropenem NDC 68083-147
Meropenem 1 g/30mL · Injection · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-147-10 | 68083014710 | 10 VIAL in 1 CARTON (68083-147-10) / 30 mL in 1 VIALMarketed from Apr 28, 2017 |
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
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206141
- Marketing start
- Listing expires
- Other FDA classes
- Carbapenems (Chemical structure)
- Identifiers
- Product ID 68083-147_3a747235-2a80-4d63-bbbf-d81538daf99aSPL ID 3a747235-2a80-4d63-bbbf-d81538daf99aSPL set ID 4e4e2c0c-df54-4229-ab90-fa671ecedd57RxCUI 1722934, 1722939UNII FV9J3JU8B1UPC 0368083147013, 0368083146016
- 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
N468083014710followed by a unit qualifier and the quantityPackage 68083-0147-10. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Meropenem 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 Meropenem for Injection and other antibacterial drugs, Meropenem 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 St…
Excerpt only. Read the full label for complete information.
About NDC 68083-147
- What is NDC 68083-147?
- 68083-147 is the product NDC for Meropenem, Meropenem 1 g/30mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Meropenem.
- What is the active ingredient?
- Meropenem.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. 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 206141
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 | Gland Pharma Limited | 68083-146 |
| Meropenem | Meropenem 500 mg/1 | Injection, Powder, For solutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-075 |
| Meropenem | Meropenem 1 g/1 | Injection, Powder, For solutionIntravenous | Xellia Pharmaceuticals USA LLC | 70594-076 |