Prescription drug · ANDA
Tazarotene NDC 0713-0765
Tazarotene .5 mg/g · Cream · Topical · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0765-31 | 0071307653100713076531 | 1 TUBE in 1 CARTON (0713-0765-31) / 30 g in 1 TUBEMarketed from Mar 10, 2025 | |
| 0713-0765-60 | 0071307656000713076560 | 1 TUBE in 1 CARTON (0713-0765-60) / 60 g in 1 TUBEMarketed from Mar 10, 2025 |
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
- Cream
- Route
- Topical
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208662
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0713-0765_3001f737-a4db-b824-e063-6294a90a784eSPL ID 3001f737-a4db-b824-e063-6294a90a784eSPL set ID fa5caf83-29d5-8229-b125-d7736928f132RxCUI 313200, 314268UNII 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
N400713076531followed by a unit qualifier and the quantityPackage 00713-0765-31. 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 cream 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. ( 1.1 ) Tazarotene cream 0.1% is indicated for the topical treatment of acne vulgaris. ( 1.2 ) 1.1 Plaque Psoriasis Tazarotene cream, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis. 1.2 Acne Vulgaris Tazarotene cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.
Excerpt only. Read the full label for complete information.
About NDC 0713-0765
- What is NDC 0713-0765?
- 0713-0765 is the product NDC for Tazarotene, Tazarotene .5 mg/g cream, 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 | 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 .5 mg/g | GelTopical | Cosette Pharmaceuticals, Inc. | 0713-0805 | 00713-0805-3100713-0805-99 |
| Tazarotene | Tazarotene 1 mg/g | CreamTopical | Mayne Pharma | 68308-745 | 68308-0745-30 |
Other NDCs under ANDA 208662
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 | CreamTopical | Cosette Pharmaceuticals, Inc. | 0713-0670 |
| Tazarotene | Tazarotene 1 mg/g | CreamTopical | Mayne Pharma | 68308-745 |