What is NDC 13548-132?

13548-132 is the product NDC for Acanya, Clindamycin phosphate 10 mg/g; Benzoyl peroxide 25 mg/g gel, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Acanya (Clindamycin Phosphate and Benzoyl Peroxide).

What is the active ingredient?

Clindamycin phosphate, Benzoyl peroxide.

Bausch Health US, LLC, NDC labeler code 13548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Acanya?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acanya NDC 13548-132 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)13548-132Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13548-0132Add 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 NDC	11-digit (billing)	Package	Copy
13548-132-50	1354801325013548013250	1 BOTTLE, PUMP in 1 CARTON (13548-132-50) / 50 g in 1 BOTTLE, PUMPMarketed from Jul 26, 2010

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): Acanya
Generic name (nonproprietary): clindamycin phosphate and benzoyl peroxide
Active ingredients: Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 25 mg/g
Dosage form: Gel
Route: Topical
Labeler: Bausch Health US, LLCNDC labeler code 13548
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050819
Marketing start: Jul 26, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)
Identifiers: Product ID 13548-132_110dde63-b7d7-49af-aa96-9daefccb84ffSPL ID 110dde63-b7d7-49af-aa96-9daefccb84ffSPL set ID 3dcd2c96-72b1-4a9f-b65c-08198d63b7dfUNII 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

N413548013250 followed by a unit qualifier and the quantity

Package 13548-0132-50. 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 Sep 30, 2020.

Indications (excerpt from the label)

ACANYA ® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. ACANYA 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)

About NDC 13548-132

What is NDC 13548-132?: 13548-132 is the product NDC for Acanya, Clindamycin phosphate 10 mg/g; Benzoyl peroxide 25 mg/g gel, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acanya (Clindamycin Phosphate and Benzoyl Peroxide).
What is the active ingredient?: Clindamycin phosphate, Benzoyl peroxide.
Who is the labeler?: Bausch Health US, LLC, NDC labeler code 13548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acanya?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Onextonclindamycin phosphate and benzoyl peroxide	Clindamycin phosphate 10 mg/g; Benzoyl peroxide 37.5 mg/g	GelTopical	Bausch Health US, LLC	0187-3050