Prescription drug · ANDA
Miconazole Nitrate NDC 0472-1738
Miconazole nitrate 200 mg/1 · Suppository · Vaginal · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0472-1738-03 | 0047217380300472173803 | 3 SUPPOSITORY in 1 CARTON (0472-1738-03)Marketed from Jan 18, 1995 |
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)
- Miconazole Nitrate
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 200 mg/1
- Dosage form
- Suppository
- Route
- Vaginal
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0472
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073508
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 0472-1738_bb1aad58-4ca7-4be9-8649-0f29e22b81f5SPL ID bb1aad58-4ca7-4be9-8649-0f29e22b81f5SPL set ID aa9e250b-f317-42cb-b8d2-e85de56f4ef7RxCUI 992765UNII VW4H1CYW1K
- 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
N400472173803followed by a unit qualifier and the quantityPackage 00472-1738-03. 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)
INDICATIONS AND USAGE Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy has not been established. As miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures. Other pathogens commonly associated with vulvovaginitis ( Trichomonas and Haemophilus vaginalis [Gardnerella] ) should be ruled out by appropriate laboratory methods.
Excerpt only. Read the full label for complete information.
About NDC 0472-1738
- What is NDC 0472-1738?
- 0472-1738 is the product NDC for Miconazole Nitrate, Miconazole nitrate 200 mg/1 suppository, listed with the FDA by Actavis Pharma, 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?
- Actavis Pharma, Inc., NDC labeler code 0472. 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 |