What is NDC 16781-462?

16781-462 is the product NDC for Clindagel (clindamycin), Clindamycin phosphate 10 mg/mL gel, listed with the FDA by Bausch Health US, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Bausch Health US, LLC, NDC labeler code 16781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clindagel?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clindagel NDC 16781-462 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16781-462Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16781-0462Add 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
16781-462-06	1678104620616781046206	6 BOTTLE in 1 CARTON (16781-462-06) / 7.3 mL in 1 BOTTLEMarketed from Jul 1, 2015 · Sample package
16781-462-75	1678104627516781046275	1 BOTTLE in 1 CARTON (16781-462-75) / 75 mL in 1 BOTTLEMarketed from Nov 25, 2013

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): Clindagel
Generic name (nonproprietary): clindamycin
Active ingredients: Clindamycin phosphate — 10 mg/mL
Dosage form: Gel
Route: Topical
Labeler: Bausch Health US, LLCNDC labeler code 16781
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050782
Marketing start: Nov 25, 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 16781-462_cb49818a-19bc-4bcc-8696-a8b749fefbe4SPL ID cb49818a-19bc-4bcc-8696-a8b749fefbe4SPL set ID f7b4e985-719a-4547-b624-94612d520991RxCUI 309332, 351330UNII 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

N416781046206 followed by a unit qualifier and the quantity

Package 16781-0462-06. 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 Jan 1, 2020.

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 CLINDAGEL (clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, CLINDAGEL 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 CLINDAGEL 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 global assessment of the results, whi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16781-462

What is NDC 16781-462?: 16781-462 is the product NDC for Clindagel (clindamycin), Clindamycin phosphate 10 mg/mL gel, listed with the FDA by Bausch Health US, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clindagel (Clindamycin).
What is the active ingredient?: Clindamycin phosphate.
Who is the labeler?: Bausch Health US, LLC, NDC labeler code 16781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clindagel?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Clindamycin Phosphate	Clindamycin phosphate 10 mg/mL	GelTopical	Oceanside Pharmaceuticals	68682-462

Clindagel (Clindamycin) NDC 16781-462