NDC codes

FDA NDC Directory
Product NDC (as listed)68682-132Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68682-0132Add 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 NDC11-digit (billing)PackageCopy
68682-132-50686820132501 BOTTLE, PUMP in 1 CARTON (68682-132-50) / 50 g in 1 BOTTLE, PUMPMarketed from Jul 2, 2018

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 and benzoyl peroxide
Active ingredients
Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 25 mg/g
Dosage form
Gel
Route
Topical
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 050819
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)
Identifiers
Product ID 68682-132_18705773-78c3-4eac-a1a7-f4ac6f667ef2SPL ID 18705773-78c3-4eac-a1a7-f4ac6f667ef2SPL set ID edae294f-cc8b-4f94-8d90-4c764fda307bRxCUI 885131UNII 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

N468682013250 followed by a unit qualifier and the quantity

Package 68682-0132-50. 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 .

Indications (excerpt from the label)

Clindamycin Phosphate and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate and Benzoyl Peroxide 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 or 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
ProductStrengthForm · routeLabelerProduct NDC
Onextonclindamycin phosphate and benzoyl peroxideClindamycin phosphate 10 mg/g; Benzoyl peroxide 37.5 mg/gGelTopicalBausch Health US, LLC0187-3050
Clindamycin Phosphate and Benzoyl PeroxideClindamycin phosphate 10 mg/g; Benzoyl peroxide 37.5 mg/gGelTopicalOceanside Pharmaceuticals68682-133
Acanyaclindamycin phosphate and benzoyl peroxideClindamycin phosphate 10 mg/g; Benzoyl peroxide 25 mg/gGelTopicalBausch Health US, LLC13548-132

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