cabtreo

Generic: clindamycin phosphate/benzoyl peroxide/adapalene

Labeler: bausch health us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cabtreo
Generic Name clindamycin phosphate/benzoyl peroxide/adapalene
Labeler bausch health us llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 1.5 mg/g, benzoyl peroxide 31 mg/g, clindamycin phosphate 12 mg/g

Manufacturer
Bausch Health US LLC

Identifiers & Regulatory

Product NDC 0187-0006
Product ID 0187-0006_338bc721-434d-cbc2-e063-6394a90abc47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216632
Listing Expiration 2026-12-31
Marketing Start 2023-10-20

Pharmacologic Class

Established (EPC)
retinoid [epc]
Chemical Structure
retinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01870006
Hyphenated Format 0187-0006

Supplemental Identifiers

RxCUI
2668198 2668204
UNII
1L4806J2QF W9WZN9A0GM EH6D7113I8
NUI
N0000175607 M0018962

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 cabtreo (source: ndc)
Generic Name clindamycin phosphate/benzoyl peroxide/adapalene (source: ndc)
Application Number NDA216632 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/g
  • 31 mg/g
  • 12 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (0187-0006-10) / 20 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (0187-0006-25) / 50 g in 1 BOTTLE, PUMP
  • 3.5 g in 1 TUBE (0187-0006-35)
source: ndc

Packages (3)

0187-0006-10 1 BOTTLE, PUMP in 1 CARTON (0187-0006-10) / 20 g in 1 BOTTLE, PUMP 0187-0006-25 1 BOTTLE, PUMP in 1 CARTON (0187-0006-25) / 50 g in 1 BOTTLE, PUMP 0187-0006-35 3.5 g in 1 TUBE (0187-0006-35)

Ingredients (3)

adapalene (1.5 mg/g) benzoyl peroxide (31 mg/g) clindamycin phosphate (12 mg/g)

Linked Drug Pages (1)

Cabtreo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "338bc721-434d-cbc2-e063-6394a90abc47", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF", "W9WZN9A0GM", "EH6D7113I8"], "rxcui": ["2668198", "2668204"], "spl_set_id": ["9468da0f-9978-4c58-8135-0274c3415084"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Bausch Health US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0187-0006-10)  / 20 g in 1 BOTTLE, PUMP", "package_ndc": "0187-0006-10", "marketing_start_date": "20231020"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (0187-0006-25)  / 50 g in 1 BOTTLE, PUMP", "package_ndc": "0187-0006-25", "marketing_start_date": "20231020"}, {"sample": true, "description": "3.5 g in 1 TUBE (0187-0006-35)", "package_ndc": "0187-0006-35", "marketing_start_date": "20231020"}], "brand_name": "Cabtreo", "product_id": "0187-0006_338bc721-434d-cbc2-e063-6394a90abc47", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Lincosamide Antibacterial [EPC]", "Lincosamides [CS]", "Neuromuscular Blockade [PE]", "Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0187-0006", "generic_name": "clindamycin phosphate/benzoyl peroxide/adapalene", "labeler_name": "Bausch Health US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cabtreo", "active_ingredients": [{"name": "ADAPALENE", "strength": "1.5 mg/g"}, {"name": "BENZOYL PEROXIDE", "strength": "31 mg/g"}, {"name": "CLINDAMYCIN PHOSPHATE", "strength": "12 mg/g"}], "application_number": "NDA216632", "marketing_category": "NDA", "marketing_start_date": "20231020", "listing_expiration_date": "20261231"}