Tazarotene NDC 45802-436

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-436Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0436Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
45802-436-01	45802043601	1 TUBE in 1 CARTON (45802-436-01) / 100 g in 1 TUBEMarketed from Jun 5, 2023
45802-436-94	45802043694	1 TUBE in 1 CARTON (45802-436-94) / 30 g in 1 TUBEMarketed from Jun 5, 2023

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): Tazarotene
Generic name (nonproprietary): tazarotene
Active ingredients: Tazarotene — .5 mg/g
Dosage form: Gel
Route: Topical
Labeler: Padagis Israel Pharmaceuticals Ltd
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213079
Marketing start: Jun 5, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 45802-436_710d0db0-54af-49fd-b2ed-77582a4b3238SPL ID 710d0db0-54af-49fd-b2ed-77582a4b3238SPL set ID ffd11dee-4266-4201-9573-1e82c2d30a63RxCUI 313199, 313201UNII 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

N445802043601 followed by a unit qualifier and the quantity

Package 45802-0436-01. 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 Jan 1, 2024.

Indications (excerpt from the label)

• Tazarotene 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 ) • Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. ( 1.2 ) 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% 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 Tazarotene gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)