clindamycin phosphate and benzoyl peroxide NDC 45802-736

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-736Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0736Add 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
45802-736-84	45802073684	1 TUBE in 1 CARTON (45802-736-84) / 45 g in 1 TUBEMarketed from Jun 26, 2012

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, benzoyl peroxide
Active ingredients: Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 50 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 090979
Marketing start: Jun 26, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 45802-736_4934962f-c507-4b32-9196-dded1e01eed1SPL ID 4934962f-c507-4b32-9196-dded1e01eed1SPL set ID 1c7040f2-e503-408a-b07e-72c7972ce78dRxCUI 1540241UNII EH6D7113I8, W9WZN9A0GM
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

N445802073684 followed by a unit qualifier and the quantity

Package 45802-0736-84. 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 26, 2023.

Indications (excerpt from the label)

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. ( 1.1 ) Limitation of Use: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. ( 1.2 ) 1.1 Indication Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. 1.2 Limitations of Use Clindamycin Phosphate and…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090979

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

FDA NDC Directory listings under ANDA 090979
Product	Strength	Form · route	Labeler	Product NDC
Neuacclindamycin phosphate and benzoyl peroxide	Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g	GelTopical	Medimetriks Pharmaceuticals	43538-176