What is NDC 78206-189?

78206-189 is the product NDC for Xaciato (clindamycin phosphate), Clindamycin phosphate 100 mg/5g gel, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Xaciato (Clindamycin phosphate).

Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Xaciato?

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.

Xaciato NDC 78206-189 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)78206-189Labeler and product segments. Claims need a package NDC.

Product NDC at billing width78206-0189Add 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
78206-189-01	7820601890178206018901	1 TUBE in 1 CARTON (78206-189-01) / 8 g in 1 TUBEMarketed from Oct 13, 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): Xaciato
Generic name (nonproprietary): clindamycin phosphate
Active ingredients: Clindamycin phosphate — 100 mg/5g
Dosage form: Gel
Route: Vaginal
Labeler: Organon LLCNDC labeler code 78206
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215650
Marketing start: Oct 13, 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 78206-189_1319a6c2-eed2-49b6-9ec8-85d44fae9b91SPL ID 1319a6c2-eed2-49b6-9ec8-85d44fae9b91SPL set ID 0423007f-28fa-4159-bf58-9174626d2347RxCUI 2587810, 2587815UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N478206018901 followed by a unit qualifier and the quantity

Package 78206-0189-01. 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 Feb 19, 2026.

Indications (excerpt from the label)

XACIATO is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older. ( 1.1 ) 1.1 Bacterial Vaginosis XACIATO ® is indicated for the treatment of bacterial vaginosis in females 12 years and older [see Use in Specific Populations ( 8.1 ) and Clinical Studies ( 14 )] .

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 78206-189

What is NDC 78206-189?: 78206-189 is the product NDC for Xaciato (clindamycin phosphate), Clindamycin phosphate 100 mg/5g gel, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Xaciato (Clindamycin phosphate).
What is the active ingredient?: Clindamycin phosphate.
Who is the labeler?: Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Xaciato?: 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.

Xaciato (Clindamycin phosphate) NDC 78206-189