adapalene

Generic: adapalene

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

Drug Facts

Product Profile

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

adapalene 3 mg/g

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-549
Product ID 46708-549_2601af7f-4657-41f1-9b14-0efda19c971b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213508
Listing Expiration 2026-12-31
Marketing Start 2025-03-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708549
Hyphenated Format 46708-549

Supplemental Identifiers

RxCUI
722111
UPC
0346708549459 0346708549466
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 (46708-549-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (46708-549-45) / 45 g in 1 TUBE
  • 1 BOTTLE, PUMP in 1 CARTON (46708-549-46) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (3)

46708-549-15 1 TUBE in 1 CARTON (46708-549-15) / 15 g in 1 TUBE 46708-549-45 1 TUBE in 1 CARTON (46708-549-45) / 45 g in 1 TUBE 46708-549-46 1 BOTTLE, PUMP in 1 CARTON (46708-549-46) / 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": "2601af7f-4657-41f1-9b14-0efda19c971b", "openfda": {"nui": ["N0000175607", "M0018962"], "upc": ["0346708549459", "0346708549466"], "unii": ["1L4806J2QF"], "rxcui": ["722111"], "spl_set_id": ["5dd6d825-f7c4-4a86-82cc-fcbb41df8542"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (46708-549-15)  / 15 g in 1 TUBE", "package_ndc": "46708-549-15", "marketing_start_date": "20250326"}, {"sample": false, "description": "1 TUBE in 1 CARTON (46708-549-45)  / 45 g in 1 TUBE", "package_ndc": "46708-549-45", "marketing_start_date": "20250326"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (46708-549-46)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "46708-549-46", "marketing_start_date": "20250326"}], "brand_name": "ADAPALENE", "product_id": "46708-549_2601af7f-4657-41f1-9b14-0efda19c971b", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "46708-549", "generic_name": "ADAPALENE", "labeler_name": "Alembic Pharmaceuticals Limited", "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": "20250326", "listing_expiration_date": "20261231"}