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 72657-158
Product ID 72657-158_ec6811f7-4728-41b1-8647-d63bb135e24e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091314
Listing Expiration 2027-12-31
Marketing Start 2023-03-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72657158
Hyphenated Format 72657-158

Supplemental Identifiers

RxCUI
307731
UPC
0372657158152 0372657158459
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
  • 1 BOTTLE, PUMP in 1 CARTON (72657-158-15) / 15 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (72657-158-45) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

72657-158-15 1 BOTTLE, PUMP in 1 CARTON (72657-158-15) / 15 g in 1 BOTTLE, PUMP 72657-158-45 1 BOTTLE, PUMP in 1 CARTON (72657-158-45) / 45 g in 1 BOTTLE, PUMP

Ingredients (1)

adapalene (1 mg/g)

Linked Drug Pages (2)

Adapalene ndc-match (0.9) Adapalene ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ec6811f7-4728-41b1-8647-d63bb135e24e", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0372657158152", "0372657158459"], "unii": ["1L4806J2QF"], "rxcui": ["307731"], "spl_set_id": ["ec6811f7-4728-41b1-8647-d63bb135e24e"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["GLENMARK THERAPEUTICS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (72657-158-15)  / 15 g in 1 BOTTLE, PUMP", "package_ndc": "72657-158-15", "marketing_start_date": "20250314"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (72657-158-45)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "72657-158-45", "marketing_start_date": "20250314"}], "brand_name": "Adapalene", "product_id": "72657-158_ec6811f7-4728-41b1-8647-d63bb135e24e", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "72657-158", "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": "20230310", "listing_expiration_date": "20271231"}