Prescription drug · NDA
Tazorac (tazarotene) NDC 16110-042
Tazarotene 1 mg/g · Gel · Cutaneous · Almirall, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16110-042-10 | 16110004210 | 1 TUBE in 1 CARTON (16110-042-10) / 100 g in 1 TUBEMarketed from Feb 21, 2020 | |
| 16110-042-30 | 16110004230 | 1 TUBE in 1 CARTON (16110-042-30) / 30 g in 1 TUBEMarketed from Feb 21, 2020 |
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)
- Tazorac
- Generic name (nonproprietary)
- tazarotene
- Active ingredients
- Tazarotene — 1 mg/g
- Dosage form
- Gel
- Route
- Cutaneous
- Labeler
- Almirall, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020600
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 16110-042_7e6df473-8f69-4d67-bd06-a24f35ab0a62SPL ID 7e6df473-8f69-4d67-bd06-a24f35ab0a62SPL set ID 4e4e4b81-420e-4492-8a74-80b692a80057RxCUI 212437, 212438, 313199, 313201UNII 81BDR9Y8PSUPC 0316110042107, 0316110042305, 0316110833309, 0316110833101
- 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 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
N416110004210followed by a unit qualifier and the quantityPackage 16110-0042-10. 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)
TAZORAC ® Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. ( 1.1 ) TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. ( 1.2 ) Limitations of Use The safety of TAZORAC Gel use on more than 20% body surface area has not been established. ( 1.3 ) 1.1 Plaque Psoriasis TAZORAC® (tazarotene) Gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. 1.2 Acne Vulgaris TAZORAC (tazarotene) Gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020600
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 |
|---|---|---|---|---|
| Tazoractazarotene | Tazarotene .5 mg/g | GelCutaneous | Almirall, LLC | 16110-833 |
- openFDA data updated
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