Prescription drug · ANDA
Tazarotene NDC 0713-0805
Tazarotene .5 mg/g · Gel · Topical · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0805-31 | 0071308053100713080531 | 1 TUBE in 1 CARTON (0713-0805-31) / 30 g in 1 TUBEMarketed from Sep 14, 2022 | |
| 0713-0805-99 | 0071308059900713080599 | 1 TUBE in 1 CARTON (0713-0805-99) / 100 g in 1 TUBEMarketed from Sep 14, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Tazarotene
- Generic name (nonproprietary)
- tazarotene
- Active ingredients
- Tazarotene — .5 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215433
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0713-0805_0b4ad65c-1d55-3e68-e063-6294a90a8e54SPL ID 0b4ad65c-1d55-3e68-e063-6294a90a8e54SPL set ID ecd718fd-c06e-4b3a-8aca-fa51e7c51a66RxCUI 313199UNII 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
N400713080531followed by a unit qualifier and the quantityPackage 00713-0805-31. 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)
Tazarotene gel, 0.05% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. ( 1.1 ) Limitations of Use The safety of tazarotene gel use on more than 20% body surface area has not been established. ( 1.3 ) 1.1 Plaque Psoriasis Tazarotene gel, 0.05% is indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. 1.3 Limitations of Use The safety of tazarotene gel use on more than 20% body surface area has not been established in psoriasis [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].
Excerpt only. Read the full label for complete information.
About NDC 0713-0805
- What is NDC 0713-0805?
- 0713-0805 is the product NDC for Tazarotene, Tazarotene .5 mg/g gel, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tazarotene.
- What is the active ingredient?
- Tazarotene.
- Who is the labeler?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tazarotene?
- 14 other product NDCs are listed under this name. See all Tazarotene NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tazarotene products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tazarotene | Tazarotene .5 mg/g | CreamTopical | Cosette Pharmaceuticals, Inc. | 0713-0765 | 00713-0765-3100713-0765-60 |
| Tazarotene | Tazarotene .5 mg/g | GelCutaneous | Solaris Pharma Corporation | 73473-309 | 73473-0309-1073473-0309-30 |
| Tazarotene | Tazarotene 1 mg/g | GelCutaneous | Solaris Pharma Corporation | 73473-310 | 73473-0310-1073473-0310-30 |
| Tazarotene | Tazarotene .5 mg/g | CreamTopical | Padagis Israel Pharmaceuticals Ltd | 45802-706 | 45802-0706-9445802-0706-96 |
| Tazarotene | Tazarotene .5 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-2420 | 72162-2420-0372162-2420-06 |
| Tazarotene | Tazarotene .5 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-436 | 45802-0436-0145802-0436-94 |
| Tazarotene | Tazarotene 1 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-442 | 45802-0442-0145802-0442-94 |
| Tazarotene | Tazarotene 1 mg/g | GelTopical | Bryant Ranch Prepack | 72162-2202 | 72162-2202-03 |
| Tazarotene | Tazarotene 1 mg/g | GelTopical | Cosette Pharmaceuticals, Inc. | 0713-0804 | 00713-0804-3100713-0804-99 |
| Tazarotene | Tazarotene 1 mg/g | CreamTopical | Mayne Pharma | 68308-745 | 68308-0745-30 |