Over-the-counter drug · ANDA
Miconazole 7 (Miconazole nitrate) NDC 0904-7734
Miconazole nitrate 20 mg/g · Cream · Vaginal · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7734-45 | 0090477344500904773445 | 1 TUBE, WITH APPLICATOR in 1 CARTON (0904-7734-45) / 45 g in 1 TUBE, WITH APPLICATORMarketed from Apr 21, 2009 |
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 7
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 20 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074164
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 0904-7734_3fe3ac94-a530-48d1-a5b4-fa0d607f6debSPL ID 3fe3ac94-a530-48d1-a5b4-fa0d607f6debSPL set ID 825ac1c5-470e-4ee1-857d-b205c26fc634RxCUI 998540UNII 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
N400904773445followed by a unit qualifier and the quantityPackage 00904-7734-45. 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)
Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Excerpt only. Read the full label for complete information.
About NDC 0904-7734
- What is NDC 0904-7734?
- 0904-7734 is the product NDC for Miconazole 7 (miconazole nitrate), Miconazole nitrate 20 mg/g cream, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Miconazole 7 (Miconazole Nitrate).
- What is the active ingredient?
- Miconazole nitrate.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. 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 7?
- 19 other product NDCs are listed under this name. See all Miconazole 7 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Miconazole 7 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 7miconazole nitrate | Miconazole nitrate 2 g/100g | CreamVaginal | HyVee Inc | 42507-769 | 42507-0769-29 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 2 g/100g | CreamVaginal | Safeway | 21130-696 | 21130-0696-29 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-160 | 83324-0160-15 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Family Dollar (FAMILY WELLNESS) | 55319-573 | 55319-0573-15 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | P & L Development, LLC | 59726-988 | 59726-0988-01 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Preferred Pharmaceuticals Inc. | 68788-7917 | 68788-7917-04 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | H2-Pharma, LLC | 61269-730 | 61269-0730-63 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | NuCare Pharmaceuticals,Inc. | 68071-3544 | 68071-3544-07 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 100 mg/g | CreamVaginal | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-347 | 49035-0347-07 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Cardinal Health (Leader) 70000 | 70000-0009 | 70000-0009-01 |
Other NDCs under ANDA 074164
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 | Walgreens | 0363-0730 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 100 mg/g | CreamVaginal | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-347 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Family Dollar (FAMILY WELLNESS) | 55319-573 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | P & L Development, LLC | 59726-988 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | H2-Pharma, LLC | 61269-730 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | QUALITY CHOICE (Chain Drug Marketing Association) | 63868-198 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | NuCare Pharmaceuticals,Inc. | 68071-3544 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Preferred Pharmaceuticals Inc. | 68788-7917 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Preferred Pharmaceuticals Inc. | 68788-8661 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | Cardinal Health (Leader) 70000 | 70000-0009 |
| Miconazole 7miconazole nitrate | Miconazole nitrate 20 mg/g | CreamVaginal | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-160 |