Over-the-counter drug · ANDA
Miconazole Nitrate NDC 51672-2035
Miconazole nitrate 20 mg/g · Cream · Vaginal · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-2035-6 | 5167220350651672203506 | 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-6) / 45 g in 1 TUBE, WITH APPLICATORMarketed from Jan 13, 1997 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Miconazole Nitrate
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 20 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074444
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 51672-2035_5b9d0a25-f604-ba22-e063-6394a90ab84fSPL ID 5b9d0a25-f604-ba22-e063-6394a90ab84f
- 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 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.
- NDC on a medical claim
N451672203506followed by a unit qualifier and the quantityPackage 51672-2035-06. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 51672-2035
- What is NDC 51672-2035?
- 51672-2035 is the product NDC for Miconazole Nitrate, Miconazole nitrate 20 mg/g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Miconazole Nitrate.
- What is the active ingredient?
- Miconazole nitrate.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Miconazole Nitrate?
- 43 other product NDCs are listed under this name. See all Miconazole Nitrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Miconazole Nitrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Miconazole Nitrateantifungal powder spray | Miconazole nitrate 20 mg/g | Aerosol, PowderTopical | Premier Brands of America Inc. | 56104-907 | 56104-0907-01 |
| Miconazole nitrateantifungal miconazole liquid continuous spray | Miconazole nitrate 20 mg/g | Aerosol, SprayTopical | Premier Brands of America Inc. | 56104-903 | 56104-0903-01 |
| Miconazole Nitrateanti-fungal powder miconazole nitrate talc free | Miconazole nitrate 20 mg/g | PowderTopical | Discount Drug Mart, Inc | 53943-976 | 53943-0976-01 |
| Miconazole Nitrateanti-fungal powder miconazole nitrate talc free | Miconazole nitrate 20 mg/g | PowderTopical | Hudson Health LLC | 72446-014 | 72446-0014-01 |
| Miconazole Nitrateathletes foot powder spray talc free | Miconazole nitrate 20 mg/g | Aerosol, PowderTopical | Chain Drug Marketing Association | 83324-233 | 83324-0233-46 |
| Miconazole Nitrate | Miconazole nitrate 20 mg/g | OintmentTopical | ALLIED TRADE LINK LLC | 84387-003 | 84387-0003-01 |
| Miconazole Nitrate | Miconazole nitrate 2 g/100g | PowderTopical | AvKARE | 42291-938 | 42291-0938-85 |
| Miconazole Nitrate | Miconazole nitrate 20 mg/g | CreamTopical | STRATEGIC SOURCING SERVICES LLC | 70677-1000 | 70677-1000-01 |
| miconazole nitrate | Miconazole nitrate 20 mg/mL | SolutionTopical | AvPAK | 50268-503 | 50268-0503-29 |
| Miconazole Nitrateantifungal miconazole powder spray | Miconazole nitrate 2.6 g/130g | Aerosol, SprayTopical | Premier Brands of America Inc. | 56104-121 | 56104-0121-01 |
Other NDCs under ANDA 074444
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 |
|---|---|---|---|---|
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | TARGET Corporation | 11673-049 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/100g | CreamVaginal | CVS Pharmacy | 69842-988 |
| Miconazole Nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | A-S Medication Solutions | 50090-4356 |