Clindamycin Phosphate NDC 72578-118

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-118Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0118Add 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
72578-118-01	72578011801	1 TUBE in 1 CARTON (72578-118-01) / 30 g in 1 TUBEMarketed from Sep 20, 2023
72578-118-02	72578011802	1 TUBE in 1 CARTON (72578-118-02) / 60 g in 1 TUBEMarketed from Sep 20, 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): Clindamycin Phosphate
Generic name (nonproprietary): clindamycin phosphate
Active ingredients: Clindamycin phosphate — 10 mg/g
Dosage form: Gel
Route: Topical
Labeler: Viona Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216587
Marketing start: Sep 20, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 72578-118_bf411e57-bd7e-4b8a-a149-ad2b0c8a52d4SPL ID bf411e57-bd7e-4b8a-a149-ad2b0c8a52d4SPL set ID 3f7a3eaa-0f10-4cbe-b035-0796413308d5RxCUI 2676585UNII 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

N472578011801 followed by a unit qualifier and the quantity

Package 72578-0118-01. 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 2, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clindamycin phosphate gel 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 216587

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

FDA NDC Directory listings under ANDA 216587
Product	Strength	Form · route	Labeler	Product NDC
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	GelTopical	Zydus Lifesciences Limited	70771-1855