effaclar

Generic: adapalene

Labeler: loreal usa products inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name effaclar
Generic Name adapalene
Labeler loreal usa products inc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 1 mg/g

Manufacturer
LOreal USA Products Inc

Identifiers & Regulatory

Product NDC 49967-592
Product ID 49967-592_e94854c5-6bb8-43db-b898-4d47a419d075
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091314
Listing Expiration 2026-12-31
Marketing Start 2024-09-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49967592
Hyphenated Format 49967-592

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 effaclar (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 TUBE in 1 CARTON (49967-592-01) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (49967-592-02) / 3 g in 1 TUBE
source: ndc

Packages (2)

49967-592-01 1 TUBE in 1 CARTON (49967-592-01) / 45 g in 1 TUBE 49967-592-02 1 TUBE in 1 CARTON (49967-592-02) / 3 g in 1 TUBE

Ingredients (1)

adapalene (1 mg/g)

Linked Drug Pages (1)

Effaclar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "e94854c5-6bb8-43db-b898-4d47a419d075", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF"], "rxcui": ["307731"], "spl_set_id": ["e94854c5-6bb8-43db-b898-4d47a419d075"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["LOreal USA Products Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (49967-592-01)  / 45 g in 1 TUBE", "package_ndc": "49967-592-01", "marketing_start_date": "20240916"}, {"sample": false, "description": "1 TUBE in 1 CARTON (49967-592-02)  / 3 g in 1 TUBE", "package_ndc": "49967-592-02", "marketing_start_date": "20240916"}], "brand_name": "Effaclar", "product_id": "49967-592_e94854c5-6bb8-43db-b898-4d47a419d075", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "49967-592", "generic_name": "Adapalene", "labeler_name": "LOreal USA Products Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Effaclar", "active_ingredients": [{"name": "ADAPALENE", "strength": "1 mg/g"}], "application_number": "ANDA091314", "marketing_category": "ANDA", "marketing_start_date": "20240916", "listing_expiration_date": "20261231"}