Adapalene And Benzoyl Peroxide NDC 45802-853

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-853Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0853Add 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
45802-853-45	45802085345	45 g in 1 BOTTLE, PUMP (45802-853-45)Marketed from Jun 2, 2022

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): Adapalene And Benzoyl Peroxide
Generic name (nonproprietary): adapalene and benzoyl peroxide
Active ingredients: Adapalene — 3 mg/gBenzoyl peroxide — 25 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 212464
Marketing start: Jun 2, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 45802-853_92dcba02-f42f-482d-8cd5-2b5ab8fa540aSPL ID 92dcba02-f42f-482d-8cd5-2b5ab8fa540aSPL set ID 92dcba02-f42f-482d-8cd5-2b5ab8fa540aRxCUI 1663745UNII 1L4806J2QF, W9WZN9A0GM
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

N445802085345 followed by a unit qualifier and the quantity

Package 45802-0853-45. 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 Jun 2, 2022.

Indications (excerpt from the label)

Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212464

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

FDA NDC Directory listings under ANDA 212464
Product	Strength	Form · route	Labeler	Product NDC
Adapalene And Benzoyl Peroxide	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Bryant Ranch Prepack	72162-1432
Adapalene And Benzoyl Peroxide	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Bryant Ranch Prepack	63629-9322