adapalene

Generic: adapalene

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene
Generic Name adapalene
Labeler alembic pharmaceuticals inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 3 mg/g

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-549
Product ID 62332-549_60dbe5ab-7710-40eb-9230-355827798446
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213508
Listing Expiration 2026-12-31
Marketing Start 2020-06-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332549
Hyphenated Format 62332-549

Supplemental Identifiers

RxCUI
722111
UPC
0362332549450 0362332549467
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 ANDA213508 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (62332-549-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (62332-549-45) / 45 g in 1 TUBE
  • 1 BOTTLE, PUMP in 1 CARTON (62332-549-46) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (3)

62332-549-15 1 TUBE in 1 CARTON (62332-549-15) / 15 g in 1 TUBE 62332-549-45 1 TUBE in 1 CARTON (62332-549-45) / 45 g in 1 TUBE 62332-549-46 1 BOTTLE, PUMP in 1 CARTON (62332-549-46) / 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": "60dbe5ab-7710-40eb-9230-355827798446", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0362332549450", "0362332549467"], "unii": ["1L4806J2QF"], "rxcui": ["722111"], "spl_set_id": ["a3b6f3c3-d615-4b00-a76f-134b75e30a50"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 TUBE in 1 CARTON (62332-549-15)  / 15 g in 1 TUBE", "package_ndc": "62332-549-15", "marketing_start_date": "20200622"}, {"sample": true, "description": "1 TUBE in 1 CARTON (62332-549-45)  / 45 g in 1 TUBE", "package_ndc": "62332-549-45", "marketing_start_date": "20200622"}, {"sample": true, "description": "1 BOTTLE, PUMP in 1 CARTON (62332-549-46)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "62332-549-46", "marketing_start_date": "20200622"}], "brand_name": "ADAPALENE", "product_id": "62332-549_60dbe5ab-7710-40eb-9230-355827798446", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "62332-549", "generic_name": "ADAPALENE", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ADAPALENE", "active_ingredients": [{"name": "ADAPALENE", "strength": "3 mg/g"}], "application_number": "ANDA213508", "marketing_category": "ANDA", "marketing_start_date": "20200622", "listing_expiration_date": "20261231"}