Clindamycin Phosphate and Benzoyl Peroxide NDC 45802-597

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-597Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0597Add 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
45802-597-01	45802059701	1 BOTTLE, PUMP in 1 CARTON (45802-597-01) / 50 g in 1 BOTTLE, PUMPMarketed from Sep 12, 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): Clindamycin Phosphate and Benzoyl Peroxide
Generic name (nonproprietary): clindamycin phosphate, benzoyl peroxide
Active ingredients: Benzoyl peroxide — 25 mg/gClindamycin phosphate — 10 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 205397
Marketing start: Sep 12, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 45802-597_fc3fe08e-5d69-42c0-bbdd-887ff1d944a6SPL ID fc3fe08e-5d69-42c0-bbdd-887ff1d944a6SPL set ID 221de6a3-c1d7-4dcf-a47b-51edaa682c2aUNII W9WZN9A0GM, EH6D7113I8
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

N445802059701 followed by a unit qualifier and the quantity

Package 45802-0597-01. 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 Oct 1, 2022.

Indications (excerpt from the label)

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205397

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

FDA NDC Directory listings under ANDA 205397
Product	Strength	Form · route	Labeler	Product NDC
Clindamycin Phosphate and Benzoyl Peroxideclindamycin phosphate, benzoyl peroxide	Benzoyl peroxide 25 mg/g; Clindamycin phosphate 10 mg/g	GelTopical	Bryant Ranch Prepack	63629-8635
Clindamycin Phosphate and Benzoyl Peroxideclindamycin phosphate, benzoyl peroxide	Benzoyl peroxide 25 mg/g; Clindamycin phosphate 10 mg/g	GelTopical	Bryant Ranch Prepack	72162-2077