Prescription drug · NDA
Likmez (Metronidazole oral) NDC 81033-066
Metronidazole 100 mg/mL · Suspension · Oral · Kesin Pharma Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81033-066-20 | 8103300662081033006620 | 200 mL in 1 BOTTLE (81033-066-20)Marketed from Oct 13, 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)
- Likmez
- Generic name (nonproprietary)
- metronidazole oral
- Active ingredients
- Metronidazole — 100 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Kesin Pharma CorporationNDC labeler code 81033
- 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 81033-066_2a82e6d7-cff9-deca-e063-6394a90a4817SPL ID 2a82e6d7-cff9-deca-e063-6394a90a4817SPL set ID 23927a8b-1641-4104-aa85-d7b7bf4ebb9dRxCUI 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
N481033006620followed by a unit qualifier and the quantityPackage 81033-0066-20. 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 81033-066
- What is NDC 81033-066?
- 81033-066 is the product NDC for Likmez (metronidazole oral), Metronidazole 100 mg/mL suspension, listed with the FDA by Kesin Pharma Corporation. It has 1 package NDC, 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?
- Kesin Pharma Corporation, NDC labeler code 81033. 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 | Saptalis Pharmaceuticals, LLC | 71656-066 | 71656-0066-2071656-0066-75 |
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 | Saptalis Pharmaceuticals, LLC | 71656-066 |