Prescription drug · NDA
Fabior (Tazarotene) NDC 51862-295
Tazarotene 1 mg/g · Aerosol, Foam · Topical · Mayne Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51862-295-10 | 5186202951051862029510 | 1 CAN in 1 CARTON (51862-295-10) / 100 g in 1 CANMarketed from Mar 17, 2017 |
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)
- Fabior
- Generic name (nonproprietary)
- tazarotene
- Active ingredients
- Tazarotene — 1 mg/g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Labeler
- Mayne PharmaNDC labeler code 51862
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202428
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 51862-295_4c23641b-0092-4d63-e063-6394a90aa62eSPL ID 4c23641b-0092-4d63-e063-6394a90aa62eSPL set ID ae0afed7-1d60-45fd-a08b-8db094618521RxCUI 1293451, 1293456UNII 81BDR9Y8PS
- Pharmacologic class
- Retinoid
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
N451862029510followed by a unit qualifier and the quantityPackage 51862-0295-10. 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)
FABIOR ® (tazarotene) Foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. FABIOR Foam is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 51862-295
- What is NDC 51862-295?
- 51862-295 is the product NDC for Fabior (tazarotene), Tazarotene 1 mg/g aerosol, foam, listed with the FDA by Mayne Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fabior (Tazarotene).
- What is the active ingredient?
- Tazarotene.
- Who is the labeler?
- Mayne Pharma, NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fabior?
- 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 NDA 202428
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 |
|---|---|---|---|---|
| tazarotene | Tazarotene 1 mg/g | Aerosol, FoamTopical | Mayne Pharma Inc. | 68308-685 |