Prescription drug · NDA
Likmez (Metronidazole oral) NDC 71656-066
Metronidazole 100 mg/mL · Suspension · Oral · Saptalis Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71656-066-20 | 7165600662071656006620 | 200 mL in 1 BOTTLE (71656-066-20)Marketed from Oct 13, 2023 | |
| 71656-066-75 | 7165600667571656006675 | 75 mL in 1 BOTTLE (71656-066-75)Marketed from Jul 22, 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)
- Likmez
- Generic name (nonproprietary)
- metronidazole oral
- Active ingredients
- Metronidazole — 100 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Saptalis Pharmaceuticals, LLCNDC labeler code 71656
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216755
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 71656-066_33133447-3893-7028-e063-6394a90aa2beSPL ID 33133447-3893-7028-e063-6394a90aa2beSPL set ID e20c14eb-5361-4a93-ab46-a7bd9aeb9b98RxCUI 2667642, 2667648UNII 140QMO216E
- Pharmacologic class
- Nitroimidazole Antimicrobial
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471656006620followed by a unit qualifier and the quantityPackage 71656-0066-20. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
LIKMEZ is a nitroimidazole antimicrobial indicated for Trichomoniasis in adults ( 1.1 ) Amebiasis in adults and pediatric patients ( 1.2 ) Anaerobic Bacterial Infections in adults ( 1.3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of LIKMEZ and other antibacterial drugs, LIKMEZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.4 ). 1.1 Trichomoniasis LIKMEZ is indicated for the treatment of: Symptomatic trichomoniasis caused by Trichomonas vaginalis in adult females and males when the diagnosis is confirmed by appropriate laboratory procedures. Asymptomatic trichomoniasis caused by Tr…
Excerpt only. Read the full label for complete information.
About NDC 71656-066
- What is NDC 71656-066?
- 71656-066 is the product NDC for Likmez (metronidazole oral), Metronidazole 100 mg/mL suspension, listed with the FDA by Saptalis Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Likmez (Metronidazole Oral).
- What is the active ingredient?
- Metronidazole.
- Who is the labeler?
- Saptalis Pharmaceuticals, LLC, NDC labeler code 71656. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Likmez?
- 1 other product NDC are listed under this name. See all Likmez NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Likmez products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Likmezmetronidazole oral | Metronidazole 100 mg/mL | SuspensionOral | Kesin Pharma Corporation | 81033-066 | 81033-0066-20 |
Other NDCs under NDA 216755
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 |
|---|---|---|---|---|
| Likmezmetronidazole oral | Metronidazole 100 mg/mL | SuspensionOral | Kesin Pharma Corporation | 81033-066 |