Clindamycin Phosphate NDC 68682-462

NDC codes

FDA NDC Directory

Product NDC (as listed)68682-462Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68682-0462Add 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
68682-462-75	68682046275	1 BOTTLE in 1 CARTON (68682-462-75) / 75 mL in 1 BOTTLEMarketed from Jun 8, 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
Generic name (nonproprietary): clindamycin phosphate
Active ingredients: Clindamycin phosphate — 10 mg/mL
Dosage form: Gel
Route: Topical
Labeler: Oceanside Pharmaceuticals
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 050782
Marketing start: Jun 8, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 68682-462_d63bb7d0-8fc2-4c01-8422-1dc9389b830fSPL ID d63bb7d0-8fc2-4c01-8422-1dc9389b830fSPL set ID 7fd5e0a2-159b-4147-947e-944eeebc1783RxCUI 309332UNII 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

N468682046275 followed by a unit qualifier and the quantity

Package 68682-0462-75. 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 Nov 11, 2024.

Indications (excerpt from the label)

CLINICAL STUDIES In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used Clindamycin Phosphate Topical Gel, 1%, once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, Clindamycin Phosphate Topical Gel applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table: Lesions Clindamycin Phosphate Topical Gel QD N=162 Vehicle Gel QD N=82 Inflammatory 51% 40% P<0.05 Noninflammatory 25% 12% Total 38% 27% There was a trend in the investigator’s …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050782

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

FDA NDC Directory listings under NDA 050782
Product	Strength	Form · route	Labeler	Product NDC
Clindagelclindamycin	Clindamycin phosphate 10 mg/mL	GelTopical	Bausch Health US, LLC	16781-462