NDC 68682-300

NDC codes

FDA NDC Directory

Product NDC (as listed)68682-300Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68682-0300Add 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
68682-300-30	68682030030	1 TUBE in 1 CARTON (68682-300-30) / 30 g in 1 TUBEMarketed from Aug 4, 2020
68682-300-60	68682030060	1 TUBE in 1 CARTON (68682-300-60) / 60 g in 1 TUBEMarketed from Aug 4, 2020

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 1.2% and Tretinoin 0.025%
Generic name (nonproprietary): clindamycin phosphate and tretinoin
Active ingredients: Clindamycin phosphate — 12 mg/gTretinoin — .25 mg/g
Dosage form: Gel
Route: Topical
Labeler: Oceanside Pharmaceuticals
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 050802
Marketing start: Aug 4, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)Retinoids (Chemical structure)
Identifiers: Product ID 68682-300_282973c6-50ee-441b-ab65-52bb582bf30cSPL ID 282973c6-50ee-441b-ab65-52bb582bf30cSPL set ID 63b2e85d-8fe5-4f18-9e85-8492c49a7520RxCUI 882548UNII EH6D7113I8, 5688UTC01R
Pharmacologic class: Lincosamide Antibacterial; Retinoid

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

N468682030030 followed by a unit qualifier and the quantity

Package 68682-0300-30. 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 1, 2020.

Indications (excerpt from the label)

Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is a lincosamide antibiotic and retinoid combination product 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)

Other NDCs under NDA 050802

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

FDA NDC Directory listings under NDA 050802
Product	Strength	Form · route	Labeler	Product NDC
Zianaclindamycin phosphate and tretinoin	Clindamycin phosphate 12 mg/g; Tretinoin .25 mg/g	GelTopical	Bausch Health US, LLC	99207-300

Clindamycin Phosphate 1.2% and Tretinoin 0.025% NDC 68682-300