adapalene

Generic: adapalene

Labeler: call inc. (dba rochester pharmaceuticals)
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name adapalene
Generic Name adapalene
Labeler call inc. (dba rochester pharmaceuticals)
Dosage Form SWAB
Routes
TOPICAL
Active Ingredients

adapalene 1 mg/mL

Manufacturer
CALL INC. (dba Rochester Pharmaceuticals)

Identifiers & Regulatory

Product NDC 49908-118
Product ID 49908-118_2b371635-a5d6-4596-e063-6394a90a8ee6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204593
Listing Expiration 2026-12-31
Marketing Start 2019-02-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49908118
Hyphenated Format 49908-118

Supplemental Identifiers

RxCUI
798061
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 ANDA204593 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 14 POUCH in 1 CARTON (49908-118-14) / 1.2 mL in 1 POUCH (49908-118-00)
source: ndc

Packages (1)

49908-118-14 14 POUCH in 1 CARTON (49908-118-14) / 1.2 mL in 1 POUCH (49908-118-00)

Ingredients (1)

adapalene (1 mg/mL)

Linked Drug Pages (1)

Adapalene ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2b371635-a5d6-4596-e063-6394a90a8ee6", "openfda": {"nui": ["N0000175607", "M0018962"], "unii": ["1L4806J2QF"], "rxcui": ["798061"], "spl_set_id": ["5ce78048-0e5c-45b5-82bf-9f61307611cd"], "pharm_class_cs": ["Retinoids [CS]"], "pharm_class_epc": ["Retinoid [EPC]"], "manufacturer_name": ["CALL INC. (dba Rochester Pharmaceuticals)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 POUCH in 1 CARTON (49908-118-14)  / 1.2 mL in 1 POUCH (49908-118-00)", "package_ndc": "49908-118-14", "marketing_start_date": "20190204"}], "brand_name": "Adapalene", "product_id": "49908-118_2b371635-a5d6-4596-e063-6394a90a8ee6", "dosage_form": "SWAB", "pharm_class": ["Retinoid [EPC]", "Retinoids [CS]"], "product_ndc": "49908-118", "generic_name": "Adapalene", "labeler_name": "CALL INC. (dba Rochester Pharmaceuticals)", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Adapalene", "active_ingredients": [{"name": "ADAPALENE", "strength": "1 mg/mL"}], "application_number": "ANDA204593", "marketing_category": "ANDA", "marketing_start_date": "20190204", "listing_expiration_date": "20261231"}