clindamycin and benzoyl peroxide NDC 68462-859

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-859Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0859Add 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
68462-859-24	68462085924	1 BOTTLE, PUMP in 1 CARTON (68462-859-24) / 35 g in 1 BOTTLE, PUMPMarketed from Sep 24, 2021
68462-859-27	68462085927	1 BOTTLE, PUMP in 1 CARTON (68462-859-27) / 50 g in 1 BOTTLE, PUMPMarketed from Sep 24, 2021

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): clindamycin and benzoyl peroxide
Generic name (nonproprietary): clindamycin and benzoyl peroxide
Active ingredients: Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 50 mg/g
Dosage form: Gel
Route: Topical
Labeler: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209252
Marketing start: Sep 24, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 68462-859_03e34592-8f1e-49cd-8a20-824d2b18b4b5SPL ID 03e34592-8f1e-49cd-8a20-824d2b18b4b5SPL set ID 76795d1b-e1f2-4d1d-b42a-f1d4448c63c0RxCUI 358917UNII EH6D7113I8, W9WZN9A0GMUPC 0368462859247, 0368462857861, 0368462484692, 0368462484869, 0368462484982
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

N468462085924 followed by a unit qualifier and the quantity

Package 68462-0859-24. 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 Jan 31, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clindamycin and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209252

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

FDA NDC Directory listings under ANDA 209252
Product	Strength	Form · route	Labeler	Product NDC
clindamycin and benzoyl peroxide	Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g	GelTopical	Glenmark Pharmaceuticals Inc., USA	68462-486
clindamycin and benzoyl peroxide	Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g	GelTopical	NorthStar RxLLC	16714-984