NDC codes

FDA NDC Directory
Product NDC (as listed)43538-170Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43538-0170Add 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
43538-170-694353801706969 APPLICATOR in 1 JAR (43538-170-69) / 1 mL in 1 APPLICATORMarketed from Jun 15, 2026
43538-170-994353801709912 PACKET in 1 CARTON (43538-170-99) / 1 mL in 1 PACKETMarketed from Jun 15, 2026

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 P
Generic name (nonproprietary)
clindamycin phosphate
Active ingredients
Clindamycin phosphate — 10 mg/mL
Dosage form
Solution
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065049
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers
Product ID 43538-170_7401e200-c94b-43dc-813c-5ec521768e7eSPL ID 7401e200-c94b-43dc-813c-5ec521768e7eSPL set ID 288371ef-96b6-4ce3-9be1-1d9d309b400cRxCUI 309333UNII 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

N443538017069 followed by a unit qualifier and the quantity

Package 43538-0170-69. 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)

INDICATIONS AND USAGE Clindacin•P ® 1% 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
ProductStrengthForm · routeLabelerProduct NDC
Clindamycin PhosphateClindamycin phosphate 10 mg/mLSolutionTopicalA-S Medication Solutions50090-1932
Clindacin ETZclindamycin phosphateClindamycin phosphate 10 mg/1SwabTopicalEurofarma, Inc.43538-172
Clindamycin PhosphateClindamycin phosphate 10 mg/mLSolutionTopicalPadagis Israel Pharmaceuticals Ltd45802-263

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