Prescription drug · ANDA
Metronidazole NDC 0168-0383
Metronidazole 7.5 mg/mL · Lotion · Topical · Fougera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0168-0383-60 | 00168038360 | 59 mL in 1 BOTTLE, PLASTIC (0168-0383-60)Marketed from May 24, 2006 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Metronidazole
- Generic name (nonproprietary)
- metronidazole
- Active ingredients
- Metronidazole — 7.5 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Fougera Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077197
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 0168-0383_76e5eaff-57c7-4120-af16-c7e8cbac8688SPL ID 76e5eaff-57c7-4120-af16-c7e8cbac8688SPL set ID 5368755a-dd37-4e34-843f-ece6bac8ef6aRxCUI 242736UNII 140QMO216EUPC 0301680383606
- 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400168038360followed by a unit qualifier and the quantityPackage 00168-0383-60. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.