Over-the-counter drug · ANDA
Miconazole 7 (Miconazole nitrate) NDC 49348-833
Miconazole nitrate 100 mg/1 · Suppository · Vaginal · Strategic Sourcing Services LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49348-833-61 | 4934808336149348083361 | 7 SUPPOSITORY in 1 APPLICATOR (49348-833-61)Marketed from Dec 9, 2011 |
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 7
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 100 mg/1
- Dosage form
- Suppository
- Route
- Vaginal
- Labeler
- Strategic Sourcing Services LLCNDC labeler code 49348
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073507
- Marketing start
- Marketing end
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 49348-833_274e7b2b-9aaa-4b8e-8cc0-a88ca1cbecdeSPL ID 274e7b2b-9aaa-4b8e-8cc0-a88ca1cbecdeSPL set ID 89132802-beb1-42f4-8da4-39918fc5c4ddRxCUI 992780UNII VW4H1CYW1KUPC 0010939046338
- 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
N449348083361followed by a unit qualifier and the quantityPackage 49348-0833-61. 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 49348-833
- What is NDC 49348-833?
- 49348-833 is the product NDC for Miconazole 7 (miconazole nitrate), Miconazole nitrate 100 mg/1 suppository, listed with the FDA by Strategic Sourcing Services LLC. 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?
- Strategic Sourcing Services LLC, NDC labeler code 49348. 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 |