Onexton NDC 0187-3050

NDC codes

FDA NDC Directory

Product NDC (as listed)0187-3050Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00187-3050Add 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
0187-3050-35	00187305035	3.5 g in 1 TUBE (0187-3050-35)Marketed from Nov 24, 2014
0187-3050-50	00187305050	1 BOTTLE, PUMP in 1 CARTON (0187-3050-50) / 50 g in 1 BOTTLE, PUMPMarketed from Nov 24, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Onexton
Generic name (nonproprietary): clindamycin phosphate and benzoyl peroxide
Active ingredients: Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 37.5 mg/g
Dosage form: Gel
Route: Topical
Labeler: Bausch Health US, LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050819
Marketing start: Nov 24, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 0187-3050_bcf2f805-f7d5-45b4-b352-a1e114e00e48SPL ID bcf2f805-f7d5-45b4-b352-a1e114e00e48SPL set ID 697e760a-c206-4565-8f4e-a8085e215827RxCUI 1598470, 1598826UNII EH6D7113I8, W9WZN9A0GMUPC 0301873050506
Pharmacologic class: Lincosamide Antibacterial

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

N400187305035 followed by a unit qualifier and the quantity

Package 00187-3050-35. 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 Jul 23, 2025.

Indications (excerpt from the label)

ONEXTON ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ONEXTON Gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide 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 NDA 050819

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

FDA NDC Directory listings under NDA 050819
Product	Strength	Form · route	Labeler	Product NDC
Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin phosphate 10 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Oceanside Pharmaceuticals	68682-132
Clindamycin Phosphate and Benzoyl Peroxide	Clindamycin phosphate 10 mg/g; Benzoyl peroxide 37.5 mg/g	GelTopical	Oceanside Pharmaceuticals	68682-133
Acanyaclindamycin phosphate and benzoyl peroxide	Clindamycin phosphate 10 mg/g; Benzoyl peroxide 25 mg/g	GelTopical	Bausch Health US, LLC	13548-132