xaciato

Generic: clindamycin phosphate

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xaciato
Generic Name clindamycin phosphate
Labeler organon llc
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

clindamycin phosphate 100 mg/5g

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-189
Product ID 78206-189_1319a6c2-eed2-49b6-9ec8-85d44fae9b91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215650
Listing Expiration 2027-12-31
Marketing Start 2023-10-13

Pharmacologic Class

Classes
decreased sebaceous gland activity [pe] lincosamide antibacterial [epc] lincosamides [cs] neuromuscular blockade [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206189
Hyphenated Format 78206-189

Supplemental Identifiers

RxCUI
2587810 2587815
UNII
EH6D7113I8

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xaciato (source: ndc)
Generic Name clindamycin phosphate (source: ndc)
Application Number NDA215650 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (78206-189-01) / 8 g in 1 TUBE
source: ndc

Packages (1)

78206-189-01 1 TUBE in 1 CARTON (78206-189-01) / 8 g in 1 TUBE

Ingredients (1)

clindamycin phosphate (100 mg/5g)

Linked Drug Pages (1)

XACIATO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "1319a6c2-eed2-49b6-9ec8-85d44fae9b91", "openfda": {"unii": ["EH6D7113I8"], "rxcui": ["2587810", "2587815"], "spl_set_id": ["0423007f-28fa-4159-bf58-9174626d2347"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (78206-189-01)  / 8 g in 1 TUBE", "package_ndc": "78206-189-01", "marketing_start_date": "20231013"}], "brand_name": "XACIATO", "product_id": "78206-189_1319a6c2-eed2-49b6-9ec8-85d44fae9b91", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]"], "product_ndc": "78206-189", "generic_name": "clindamycin phosphate", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XACIATO", "active_ingredients": [{"name": "CLINDAMYCIN PHOSPHATE", "strength": "100 mg/5g"}], "application_number": "NDA215650", "marketing_category": "NDA", "marketing_start_date": "20231013", "listing_expiration_date": "20271231"}