Over-the-counter drug · ANDA
signature care tioconazole 1 (Tioconazole) NDC 21130-060
Tioconazole 6.5 g/100g · Ointment · Vaginal · Safeway
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-060-54 | 2113000605421130006054 | 1 POUCH in 1 CARTON (21130-060-54) / 1 TUBE, WITH APPLICATOR in 1 POUCH / 4.6 g in 1 TUBE, WITH APPLICATORMarketed from Sep 24, 2015 |
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)
- signature care tioconazole 1
- Generic name (nonproprietary)
- tioconazole
- Active ingredients
- Tioconazole — 6.5 g/100g
- Dosage form
- Ointment
- Route
- Vaginal
- Labeler
- SafewayNDC labeler code 21130
- 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 21130-060_a6c0d30b-1e93-4b4e-bd13-c480eab4aeceSPL ID a6c0d30b-1e93-4b4e-bd13-c480eab4aeceSPL set ID 22ac4774-87b4-437f-8520-e4a4ed6e1c55RxCUI 198380UNII 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 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
N421130006054followed by a unit qualifier and the quantityPackage 21130-0060-54. 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 21130-060
- What is NDC 21130-060?
- 21130-060 is the product NDC for signature care tioconazole 1 (tioconazole), Tioconazole 6.5 g/100g ointment, listed with the FDA by Safeway. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- signature care tioconazole 1 (Tioconazole).
- What is the active ingredient?
- Tioconazole.
- Who is the labeler?
- Safeway, NDC labeler code 21130. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for signature care 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 |
| 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 |
| Monistat Tioconazole 1tioconazole | Tioconazole 6.5 g/100g | OintmentTopical | Insight Pharmaceuticals LLC | 63736-413 |
| 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 |