Clindacin ETZ (clindamycin phosphate) NDC 43538-172

NDC codes

FDA NDC Directory

Product NDC (as listed)43538-172Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43538-0172Add 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
43538-172-60	43538017260	60 PACKET in 1 CARTON (43538-172-60) / 1 SWAB in 1 PACKETMarketed from Jun 15, 2013
43538-172-99	43538017299	12 PACKET in 1 CARTON (43538-172-99) / 1 SWAB in 1 PACKETMarketed from Oct 24, 2023

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): Clindacin ETZ
Generic name (nonproprietary): clindamycin phosphate
Active ingredients: Clindamycin phosphate — 10 mg/1
Dosage form: Swab
Route: Topical
Labeler: Eurofarma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065049
Marketing start: Jun 15, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 43538-172_24aae3bd-54de-429d-9587-c156b5949f40SPL ID 24aae3bd-54de-429d-9587-c156b5949f40SPL set ID 89fed26e-1cad-4c0b-8695-d6f3562ba8d5RxCUI 797274, 1091339UNII 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

N443538017260 followed by a unit qualifier and the quantity

Package 43538-0172-60. 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 Apr 2, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clindacin ® ETZ is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065049

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

FDA NDC Directory listings under ANDA 065049
Product	Strength	Form · route	Labeler	Product NDC
Clindamycin Phosphate	Clindamycin phosphate 10 mg/mL	SolutionTopical	A-S Medication Solutions	50090-1932
Clindacin Pclindamycin phosphate	Clindamycin phosphate 10 mg/mL	SolutionTopical	Eurofarma, Inc.	43538-170
Clindamycin Phosphate	Clindamycin phosphate 10 mg/mL	SolutionTopical	Padagis Israel Pharmaceuticals Ltd	45802-263