adapalene

Generic: adapalene

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene
Generic Name adapalene
Labeler sun pharmaceutical industries, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

adapalene 3 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-1377
Product ID 51672-1377_38f40203-5ac8-283b-e063-6394a90a0e0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208322
Listing Expiration 2026-12-31
Marketing Start 2016-06-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516721377
Hyphenated Format 51672-1377

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 (source: ndc)
Generic Name adapalene (source: ndc)
Application Number ANDA208322 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-1377-6) / 45 g in 1 TUBE
  • 1 BOTTLE, PUMP in 1 CARTON (51672-1377-9) / 45 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

51672-1377-6 1 TUBE in 1 CARTON (51672-1377-6) / 45 g in 1 TUBE 51672-1377-9 1 BOTTLE, PUMP in 1 CARTON (51672-1377-9) / 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": "38f40203-5ac8-283b-e063-6394a90a0e0e", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF"], "rxcui": ["722111"], "spl_set_id": ["ca37576a-09aa-4ee8-9dc4-8ad76b999fcf"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-1377-6)  / 45 g in 1 TUBE", "package_ndc": "51672-1377-6", "marketing_start_date": "20160623"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (51672-1377-9)  / 45 g in 1 BOTTLE, PUMP", "package_ndc": "51672-1377-9", "marketing_start_date": "20160623"}], "brand_name": "Adapalene", "product_id": "51672-1377_38f40203-5ac8-283b-e063-6394a90a0e0e", "dosage_form": "GEL", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "51672-1377", "generic_name": "Adapalene", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adapalene", "active_ingredients": [{"name": "ADAPALENE", "strength": "3 mg/g"}], "application_number": "ANDA208322", "marketing_category": "ANDA", "marketing_start_date": "20160623", "listing_expiration_date": "20261231"}