What is NDC 68462-301?

68462-301 is the product NDC for adapalene and benzoyl peroxide, Adapalene 1 mg/g; Benzoyl peroxide 25 mg/g gel, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for adapalene and benzoyl peroxide?

15 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

adapalene and benzoyl peroxide NDC 68462-301

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-301Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0301Add 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
68462-301-47	68462030147	1 BOTTLE, PUMP in 1 CARTON (68462-301-47) / 45 g in 1 BOTTLE, PUMPMarketed from Nov 8, 2019
68462-301-55	68462030155	45 g in 1 TUBE (68462-301-55)Marketed from Nov 8, 2019

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 — 1 mg/gBenzoyl peroxide — 25 mg/g
Dosage form: Gel
Route: Topical
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208108
Marketing start: Nov 8, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 68462-301_194a1ade-7163-4a56-ad50-6220398ede14SPL ID 194a1ade-7163-4a56-ad50-6220398ede14SPL set ID fc8e868f-9699-4ae6-83d5-fa27789336cdRxCUI 829539UNII 1L4806J2QF, W9WZN9A0GMUPC 0368462301470
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

N468462030147 followed by a unit qualifier and the quantity

Package 68462-0301-47. 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 Nov 23, 2026.

Indications (excerpt from the label)

Adapalene and benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adapalene and benzoyl peroxide gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-301

What is NDC 68462-301?: 68462-301 is the product NDC for adapalene and benzoyl peroxide, Adapalene 1 mg/g; Benzoyl peroxide 25 mg/g gel, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: adapalene and benzoyl peroxide.
What is the active ingredient?: Adapalene, Benzoyl peroxide.
Who is the labeler?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for adapalene and benzoyl peroxide?: 15 other product NDCs are listed under this name. See all adapalene and benzoyl peroxide 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 adapalene and benzoyl peroxide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Adapalene and benzoyl peroxide	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Aurobindo Pharma Limited	59651-604	59651-0604-4659651-0604-60
Adapalene And Benzoyl Peroxideadapalene and benzoyl peroxide topical	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Alembic Pharmaceuticals Limited	46708-662	46708-0662-45
Adapalene and benzoyl peroxide	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Teva Pharmaceuticals, Inc.	0480-3154	00480-3154-45
Adapalene And Benzoyl Peroxideadapalene and benzoyl peroxide topical	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Alembic Pharmaceuticals Inc.	62332-662	62332-0662-45
Adapalene and benzoyl peroxide	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Zydus Lifesciences Limited	70771-1716	70771-1716-0370771-1716-04
Adapalene and benzoyl peroxide	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Viona Pharmaceuticals Inc	72578-119	72578-0119-0272578-0119-04
Adapalene And Benzoyl Peroxide	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Padagis Israel Pharmaceuticals Ltd	45802-853	45802-0853-45
Adapalene And Benzoyl Peroxide	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Bryant Ranch Prepack	63629-9322	63629-9322-01
Adapalene And Benzoyl Peroxide	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Bryant Ranch Prepack	72162-1432	72162-1432-02
adapalene and benzoyl peroxide	Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Mayne Pharma Inc.	68308-662	68308-0662-45

All 16 adapalene and benzoyl peroxide NDCs