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 NDC11-digit (billing)PackageCopy
45802-436-0145802043601458020436011 TUBE in 1 CARTON (45802-436-01) / 100 g in 1 TUBEMarketed from Jun 5, 2023
45802-436-9445802043694458020436941 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 LtdNDC labeler code 45802
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213079
Marketing start
Listing expires
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 .

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)

About NDC 45802-436

What is NDC 45802-436?
45802-436 is the product NDC for Tazarotene, Tazarotene .5 mg/g gel, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. 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?
Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tazarotene NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TazaroteneTazarotene .5 mg/gCreamTopicalCosette Pharmaceuticals, Inc.0713-076500713-0765-3100713-0765-60
TazaroteneTazarotene .5 mg/gGelCutaneousSolaris Pharma Corporation73473-30973473-0309-1073473-0309-30
TazaroteneTazarotene 1 mg/gGelCutaneousSolaris Pharma Corporation73473-31073473-0310-1073473-0310-30
TazaroteneTazarotene .5 mg/gCreamTopicalPadagis Israel Pharmaceuticals Ltd45802-70645802-0706-9445802-0706-96
TazaroteneTazarotene .5 mg/gCreamTopicalBryant Ranch Prepack72162-242072162-2420-0372162-2420-06
TazaroteneTazarotene 1 mg/gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-44245802-0442-0145802-0442-94
TazaroteneTazarotene 1 mg/gGelTopicalBryant Ranch Prepack72162-220272162-2202-03
TazaroteneTazarotene 1 mg/gGelTopicalCosette Pharmaceuticals, Inc.0713-080400713-0804-3100713-0804-99
TazaroteneTazarotene .5 mg/gGelTopicalCosette Pharmaceuticals, Inc.0713-080500713-0805-3100713-0805-99
TazaroteneTazarotene 1 mg/gCreamTopicalMayne Pharma68308-74568308-0745-30

All 15 Tazarotene NDCs

Other NDCs under ANDA 213079

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 213079
ProductStrengthForm · routeLabelerProduct NDC
TazaroteneTazarotene 1 mg/gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-442
TazaroteneTazarotene 1 mg/gGelTopicalBryant Ranch Prepack72162-2202

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