adapalene gel usp, 0.3%

Generic: adapalene gel usp, 0.3%

Labeler: encube ethicals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene gel usp, 0.3%
Generic Name adapalene gel usp, 0.3%
Labeler encube ethicals, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 3 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-051
Product ID 21922-051_2e5f2180-7624-4bb6-892d-e63491da2591
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200298
Listing Expiration 2026-12-31
Marketing Start 2023-08-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922051
Hyphenated Format 21922-051

Supplemental Identifiers

RxCUI
722111
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 gel usp, 0.3% (source: ndc)
Generic Name adapalene gel usp, 0.3% (source: ndc)
Application Number ANDA200298 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-051-06) / 45 g in 1 TUBE
  • 1 BOTTLE, PUMP in 1 CARTON (21922-051-50) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

21922-051-06 1 TUBE in 1 CARTON (21922-051-06) / 45 g in 1 TUBE 21922-051-50 1 BOTTLE, PUMP in 1 CARTON (21922-051-50) / 45 g in 1 BOTTLE, PUMP

Ingredients (1)

adapalene (3 mg/g)

Linked Drug Pages (1)

Adapalene Gel USP, 0.3% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2e5f2180-7624-4bb6-892d-e63491da2591", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF"], "rxcui": ["722111"], "spl_set_id": ["56045eee-e84d-467a-9e12-e62bd474ed8a"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-051-06)  / 45 g in 1 TUBE", "package_ndc": "21922-051-06", "marketing_start_date": "20230810"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (21922-051-50)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "21922-051-50", "marketing_start_date": "20230810"}], "brand_name": "Adapalene Gel USP, 0.3%", "product_id": "21922-051_2e5f2180-7624-4bb6-892d-e63491da2591", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "21922-051", "generic_name": "Adapalene Gel USP, 0.3%", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adapalene Gel USP, 0.3%", "active_ingredients": [{"name": "ADAPALENE", "strength": "3 mg/g"}], "application_number": "ANDA200298", "marketing_category": "ANDA", "marketing_start_date": "20230807", "listing_expiration_date": "20261231"}