Over-the-counter drug · ANDA
Monistat Tioconazole 1 (Tioconazole) NDC 63736-413
Tioconazole 6.5 g/100g · Ointment · Topical · Insight Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63736-413-01 | 6373604130163736041301 | 1 APPLICATOR in 1 CARTON (63736-413-01) / 4.6 g in 1 APPLICATORMarketed from Nov 21, 2001 |
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)
- Monistat Tioconazole 1
- Generic name (nonproprietary)
- tioconazole
- Active ingredients
- Tioconazole — 6.5 g/100g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Insight Pharmaceuticals LLCNDC labeler code 63736
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075915
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 63736-413_5aafb76b-fbad-b204-e063-6294a90ae85bSPL ID 5aafb76b-fbad-b204-e063-6294a90ae85bSPL set ID 587e42b4-cbdc-4a03-afae-f9e5e6605937RxCUI 198380, 1661176UNII S57Y5X1117
- 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463736041301followed by a unit qualifier and the quantityPackage 63736-0413-01. 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 63736-413
- What is NDC 63736-413?
- 63736-413 is the product NDC for Monistat Tioconazole 1 (tioconazole), Tioconazole 6.5 g/100g ointment, listed with the FDA by Insight Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Monistat Tioconazole 1 (Tioconazole).
- What is the active ingredient?
- Tioconazole.
- Who is the labeler?
- Insight Pharmaceuticals LLC, NDC labeler code 63736. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Monistat Tioconazole 1?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 075915
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 |
|---|---|---|---|---|
| foster and thrive tioconazoletioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Strategic Sourcing Services LLC | 70677-1224 |
| signature care tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Safeway | 21130-060 |
| Vagistattioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Combe Incorporated | 11509-0426 |
| Tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Safeway | 21130-781 |
| tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Meijer Distribution Inc | 41250-426 |
| Up and up tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Target Corporation | 11673-426 |
| basic care tioconazoletioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Amazon.com Services LLC | 72288-426 |
| tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | CVS Pharmacy | 59779-718 |
| good sense tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | L. Perrigo Company | 0113-0426 |
| CareOne Tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | American Sales Company | 41520-426 |
| Topcare Tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Topco Associates LLC | 36800-426 |
| dg health tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Dolgencorp Inc | 55910-731 |
| Equate tioconazole 1 daytioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Wal-Mart Stores Inc | 49035-426 |
| Tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Walgreen Company | 0363-0426 |
| Leader Tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Cardinal Health 110, LLC. dba Leader | 70000-0357 |
| Tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | Amazon.com Services LLC | 72288-222 |
| Tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentVaginal | H E B | 37808-426 |