adapalene

Generic: adapalene

Labeler: glenmark therapeutics inc., usa
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene
Generic Name adapalene
Labeler glenmark therapeutics inc., usa
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 1 mg/g

Manufacturer
GLENMARK THERAPEUTICS INC., USA

Identifiers & Regulatory

Product NDC 72657-102
Product ID 72657-102_9f8d3f10-5647-4e78-8b8f-b6c651db3e3f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091314
Listing Expiration 2027-12-31
Marketing Start 2023-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72657102
Hyphenated Format 72657-102

Supplemental Identifiers

RxCUI
307731
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 ANDA091314 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • Package/Label Principal Display Panel NDC 72657-102-17 Adapalene Gel USP, 0.1% NET WT. 0.5 OZ (15 g) carton15mg
  • Package/Label Principal Display Panel NDC 72657-102-55 Adapalene Gel USP, 0.1% NET WT. 1.6 OZ (45 g) carton45gm
source: label

Packages (0)

No package records.

Ingredients (1)

adapalene (1 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": "9f8d3f10-5647-4e78-8b8f-b6c651db3e3f", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF"], "rxcui": ["307731"], "spl_set_id": ["5d5340d6-e1da-46e4-973c-40cf8e907aa3"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["GLENMARK THERAPEUTICS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Adapalene", "product_id": "72657-102_9f8d3f10-5647-4e78-8b8f-b6c651db3e3f", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "72657-102", "generic_name": "Adapalene", "labeler_name": "GLENMARK THERAPEUTICS INC., USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Adapalene", "active_ingredients": [{"name": "ADAPALENE", "strength": "1 mg/g"}], "application_number": "ANDA091314", "marketing_category": "ANDA", "marketing_start_date": "20230101", "listing_expiration_date": "20271231"}