adapalene

Generic: adapalene

Labeler: mayne pharma commercial llc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene
Generic Name adapalene
Labeler mayne pharma commercial llc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 3 mg/g

Manufacturer
Mayne Pharma Commercial LLC.

Identifiers & Regulatory

Product NDC 68308-666
Product ID 68308-666_86366747-19bc-4279-8e62-afc7c8682e4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021753
Listing Expiration 2026-12-31
Marketing Start 2024-02-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308666
Hyphenated Format 68308-666

Supplemental Identifiers

RxCUI
722111
UNII
1L4806J2QF
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 adapalene (source: ndc)
Generic Name adapalene (source: ndc)
Application Number NDA021753 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68308-666-25) / 45 g in 1 TUBE
  • 1 BOTTLE, PUMP in 1 CARTON (68308-666-45) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

68308-666-25 1 TUBE in 1 CARTON (68308-666-25) / 45 g in 1 TUBE 68308-666-45 1 BOTTLE, PUMP in 1 CARTON (68308-666-45) / 45 g in 1 BOTTLE, PUMP

Ingredients (1)

adapalene (3 mg/g)

Linked Drug Pages (1)

ADAPALENE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "86366747-19bc-4279-8e62-afc7c8682e4b", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF"], "rxcui": ["722111"], "spl_set_id": ["9a0d9a0d-a9f3-4eb9-be76-166ef182d13a"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Mayne Pharma Commercial LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68308-666-25)  / 45 g in 1 TUBE", "package_ndc": "68308-666-25", "marketing_start_date": "20240226"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68308-666-45)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "68308-666-45", "marketing_start_date": "20240226"}], "brand_name": "ADAPALENE", "product_id": "68308-666_86366747-19bc-4279-8e62-afc7c8682e4b", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "68308-666", "generic_name": "ADAPALENE", "labeler_name": "Mayne Pharma Commercial LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ADAPALENE", "active_ingredients": [{"name": "ADAPALENE", "strength": "3 mg/g"}], "application_number": "NDA021753", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240226", "listing_expiration_date": "20261231"}