Prescription drug · NDA
Oravig (Miconazole) NDC 61825-303
Miconazole 50 mg/1 · Tablet · Buccal · Galt Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61825-303-14 | 6182503031461825030314 | 14 TABLET in 1 BOTTLE (61825-303-14)Marketed from Dec 31, 2021 |
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)
- Oravig
- Generic name (nonproprietary)
- miconazole
- Active ingredients
- Miconazole — 50 mg/1
- Dosage form
- Tablet
- Route
- Buccal
- Labeler
- Galt Pharmaceuticals, LLCNDC labeler code 61825
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022404
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 61825-303_47da8a7f-0d47-f1cd-e063-6394a90a84adSPL ID 47da8a7f-0d47-f1cd-e063-6394a90a84adSPL set ID dc2427ff-e566-4b48-b289-9e51c011250aRxCUI 998548, 998550UNII 7NNO0D7S5M
- Pharmacologic class
- Azole Antifungal
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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N461825030314followed by a unit qualifier and the quantityPackage 61825-0303-14. 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)
ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults. ORAVIG is an azole antifungal indicated for the local treatment of oropharyngeal candidiasis in adults.
Excerpt only. Read the full label for complete information.
About NDC 61825-303
- What is NDC 61825-303?
- 61825-303 is the product NDC for Oravig (miconazole), Miconazole 50 mg/1 tablet, listed with the FDA by Galt Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oravig (Miconazole).
- What is the active ingredient?
- Miconazole.
- Who is the labeler?
- Galt Pharmaceuticals, LLC, NDC labeler code 61825. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oravig?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.