Adapalene NDC 62332-549

NDC codes

FDA NDC Directory

Product NDC (as listed)62332-549Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62332-0549Add 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
62332-549-15	62332054915	1 TUBE in 1 CARTON (62332-549-15) / 15 g in 1 TUBEMarketed from Jun 22, 2020 · Sample package
62332-549-45	62332054945	1 TUBE in 1 CARTON (62332-549-45) / 45 g in 1 TUBEMarketed from Jun 22, 2020 · Sample package
62332-549-46	62332054946	1 BOTTLE, PUMP in 1 CARTON (62332-549-46) / 45 g in 1 BOTTLE, PUMPMarketed from Jun 22, 2020 · Sample package

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
Generic name (nonproprietary): adapalene
Active ingredients: Adapalene — 3 mg/g
Dosage form: Gel
Route: Topical
Labeler: Alembic Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213508
Marketing start: Jun 22, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 62332-549_60dbe5ab-7710-40eb-9230-355827798446SPL ID 60dbe5ab-7710-40eb-9230-355827798446SPL set ID a3b6f3c3-d615-4b00-a76f-134b75e30a50RxCUI 722111UNII 1L4806J2QFUPC 0362332549450, 0362332549467
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

N462332054915 followed by a unit qualifier and the quantity

Package 62332-0549-15. 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 3, 2024.

Indications (excerpt from the label)

Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in 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 213508

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

FDA NDC Directory listings under ANDA 213508
Product	Strength	Form · route	Labeler	Product NDC
Adapalene	Adapalene 3 mg/g	GelTopical	Alembic Pharmaceuticals Limited	46708-549