adapalene

Generic: adapalene

Labeler: rugby laboratories, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene
Generic Name adapalene
Labeler rugby laboratories, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 1 mg/g

Manufacturer
RUGBY LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 0536-1412
Product ID 0536-1412_38f5232a-92be-ed71-e063-6294a90a8417
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215940
Listing Expiration 2026-12-31
Marketing Start 2024-02-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05361412
Hyphenated Format 0536-1412

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 adapalene (source: ndc)
Generic Name adapalene (source: ndc)
Application Number ANDA215940 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (0536-1412-20) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (0536-1412-26) / 45 g in 1 TUBE
source: ndc

Packages (2)

0536-1412-20 1 TUBE in 1 CARTON (0536-1412-20) / 15 g in 1 TUBE 0536-1412-26 1 TUBE in 1 CARTON (0536-1412-26) / 45 g in 1 TUBE

Ingredients (1)

adapalene (1 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": "38f5232a-92be-ed71-e063-6294a90a8417", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF"], "rxcui": ["307731"], "spl_set_id": ["330bc2b3-e064-4189-9c47-9c5a50aa4dde"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["RUGBY LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0536-1412-20)  / 15 g in 1 TUBE", "package_ndc": "0536-1412-20", "marketing_start_date": "20240220"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0536-1412-26)  / 45 g in 1 TUBE", "package_ndc": "0536-1412-26", "marketing_start_date": "20240220"}], "brand_name": "ADAPALENE", "product_id": "0536-1412_38f5232a-92be-ed71-e063-6294a90a8417", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "0536-1412", "generic_name": "ADAPALENE", "labeler_name": "RUGBY LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ADAPALENE", "active_ingredients": [{"name": "ADAPALENE", "strength": "1 mg/g"}], "application_number": "ANDA215940", "marketing_category": "ANDA", "marketing_start_date": "20240220", "listing_expiration_date": "20261231"}