Over-the-counter drug · ANDA
Miconazole 3 (Miconazole nitrate) NDC 11673-391
Miconazole nitrate 40 mg/g · Cream · Vaginal · TARGET Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11673-391-06 | 1167303910611673039106 | 1 TUBE, WITH APPLICATOR in 1 CARTON (11673-391-06) / 25 g in 1 TUBE, WITH APPLICATORMarketed from Oct 14, 2020 |
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)
- Miconazole 3
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 40 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- TARGET CorporationNDC labeler code 11673
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076773
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 11673-391_3a38916c-83b0-dad7-e063-6394a90a8f69SPL ID 3a38916c-83b0-dad7-e063-6394a90a8f69SPL set ID 12a2e441-4fdf-4c5e-b033-ba05ef12fc2fRxCUI 998544UNII 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
N411673039106followed by a unit qualifier and the quantityPackage 11673-0391-06. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Use treats vaginal yeast infections
Excerpt only. Read the full label for complete information.
About NDC 11673-391
- What is NDC 11673-391?
- 11673-391 is the product NDC for Miconazole 3 (miconazole nitrate), Miconazole nitrate 40 mg/g cream, listed with the FDA by TARGET Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Miconazole 3 (Miconazole Nitrate).
- What is the active ingredient?
- Miconazole nitrate.
- Who is the labeler?
- TARGET Corporation, NDC labeler code 11673. 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 3?
- 10 other product NDCs are listed under this name. See all Miconazole 3 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Miconazole 3 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 3miconazole nitrate | — | Kit | Safeway | 21130-759 | 21130-0759-00 |
| Miconazole 3miconazole nitrate | — | Kit | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-689 | 51316-0689-00 |
| miconazole 3miconazole nitrate | — | Kit | Rite Aid Corporation | 11822-0209 | 11822-0209-00 |
| miconazole 3miconazole nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | Walgreen Company | 0363-2070 | 00363-2070-14 |
| Miconazole 3miconazole nitrate | — | Kit | Meijer Distribution Inc | 41250-982 | 41250-0982-00 |
| Miconazole 3miconazole nitrate | — | Kit | CVS Pharmacy | 59779-839 | 59779-0839-00 |
| Miconazole 3miconazole nitrate | — | Kit | Rite Aid Corporation | 11822-0800 | 11822-0800-00 |
| miconazole 3miconazole nitrate | — | Kit | H E B | 37808-242 | 37808-0242-00 |
| miconazole 3miconazole nitrate | — | Kit | Kroger Company | 30142-081 | 30142-0081-00 |
| miconazole 3miconazole nitrate | — | Kit | Meijer Distribution Inc | 41250-081 | 41250-0081-00 |
Other NDCs under ANDA 076773
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 |
|---|---|---|---|---|
| Lagicam antifungalmiconazole nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | Genomma Lab USA, Inc. | 50066-070 |
| Miconazole Nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | Sun Pharmaceutical Industries, Inc. | 51672-2070 |