Over-the-counter drug · ANDA
Miconazole (Miconazole nitrate) NDC 37808-928
Miconazole nitrate 40 mg/g · Cream · Vaginal · H E B
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 37808-928-14 | 3780809281437808092814 | 1 TUBE in 1 CARTON (37808-928-14) / 5 g in 1 TUBEMarketed from Mar 17, 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
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 40 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- H E BNDC labeler code 37808
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091366
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 37808-928_6b7d09f4-b857-4e61-9541-2a143bd5a8eeSPL ID 6b7d09f4-b857-4e61-9541-2a143bd5a8eeSPL set ID 83305fd6-2154-4b1b-aaec-3e2e56708fdbRxCUI 998544, 2288429UNII 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
N437808092814followed by a unit qualifier and the quantityPackage 37808-0928-14. 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)
Uses • treats vaginal yeast infections
Excerpt only. Read the full label for complete information.
About NDC 37808-928
- What is NDC 37808-928?
- 37808-928 is the product NDC for Miconazole (miconazole nitrate), Miconazole nitrate 40 mg/g cream, listed with the FDA by H E B. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Miconazole (Miconazole nitrate).
- What is the active ingredient?
- Miconazole nitrate.
- Who is the labeler?
- H E B, NDC labeler code 37808. 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?
- 1 other product NDC are listed under this name. See all Miconazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Miconazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Miconazolemiconazole nitrate | Miconazole nitrate 20 mg/g | CreamTopical | Chain Drug Consortium, LLC | 68016-291 | 68016-0291-01 |
Other NDCs under ANDA 091366
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 |
|---|---|---|---|---|
| basic care miconazole 3miconazole nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | Amazon.com Services LLC | 72288-070 |
| Good Sense Miconazole 3miconazole nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | L. Perrigo Company | 0113-7110 |
| HERS Miconazole 3miconazole nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | Hims Inc | 71730-070 |
| miconazole 3miconazole nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | Walgreen Company | 0363-2070 |
| Topco Miconazole 3miconazole nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | Topco Associates LLC | 36800-782 |