Prescription drug · ANDA
Meropenem NDC 81962-001
Meropenem 1 g/20mL · Injection · Intravenous · BROOKS STERISCIENCE LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81962-001-01 | 8196200010181962000101 | 1 VIAL in 1 CARTON (81962-001-01) / 20 mL in 1 VIALMarketed from May 31, 2023 | |
| 81962-001-02 | 8196200010281962000102 | 10 VIAL in 1 CARTON (81962-001-02) / 20 mL in 1 VIALMarketed from May 31, 2023 | |
| 81962-001-03 | 8196200010381962000103 | 25 VIAL in 1 CARTON (81962-001-03) / 20 mL in 1 VIALMarketed from May 31, 2023 |
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/20mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- BROOKS STERISCIENCE LIMITEDNDC labeler code 81962
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216154
- Marketing start
- Listing expires
- Other FDA classes
- Carbapenems (Chemical structure)
- Identifiers
- Product ID 81962-001_4caa1d3a-1dba-7392-e063-6294a90a0080SPL ID 4caa1d3a-1dba-7392-e063-6294a90a0080SPL set ID 58e165b7-e230-4459-abf9-06d5ca1dd7b2RxCUI 1722934, 1722939UNII FV9J3JU8B1UPC 0381962000018, 0381962001022
- 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
N481962000101followed by a unit qualifier and the quantityPackage 81962-0001-01. 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 Structur…
Excerpt only. Read the full label for complete information.
About NDC 81962-001
- What is NDC 81962-001?
- 81962-001 is the product NDC for Meropenem, Meropenem 1 g/20mL injection, listed with the FDA by BROOKS STERISCIENCE LIMITED. It has 3 package NDCs, 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?
- BROOKS STERISCIENCE LIMITED, NDC labeler code 81962. 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?
- 42 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 216154
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 | ARMAS PHARMACEUTICALS INC | 72485-411 |
| Meropenem | Meropenem 1 g/20mL | InjectionIntravenous | ARMAS PHARMACEUTICALS INC | 72485-412 |
| Meropenem | Meropenem 1 g/20mL | InjectionIntravenous | Civica, Inc. | 72572-410 |
| Meropenem | Meropenem 500 mg/20mL | InjectionIntravenous | Civica, Inc. | 72572-412 |
| Meropenem | Meropenem 500 mg/20mL | InjectionIntravenous | BROOKS STERISCIENCE LIMITED | 81962-000 |