FDA.reportPublic FDA data

Adapalene Topical Solution

Product NDC
0682-0053
11-digit product format
006820053
Labeler code
0682
Product ID
0682-0053_804c7131-c45c-e558-e053-2991aa0a291c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adapalene
Dosage form
SWAB
Route
TOPICAL
Labeler
Marnel Pharmaceuticals, Inc.
Application
ANDA204593
Marketing category
ANDA
Marketing start
2018-08-27
Marketing end
0000-00-00
Substance
ADAPALENE
Active strength
1 mg/mL
Pharmacologic classes
Retinoid [EPC],Retinoids [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0682-0053-142020-10-22C16284748780-1ab0e2407-353c-f274-e053-dbdaa90a64719c06b971-8621-4235-ae27-36184c22a6e0
0682-0053-302020-10-22C16284748780-1ab0e2407-353c-f274-e053-dbdaa90a64719c06b971-8621-4235-ae27-36184c22a6e0
0682-0053-142020-09-27C16284748780-1ab0e2407-353c-f274-e053-dbdaa90a64719c06b971-8621-4235-ae27-36184c22a6e0
0682-0053-302020-09-27C16284748780-1ab0e2407-353c-f274-e053-dbdaa90a64719c06b971-8621-4235-ae27-36184c22a6e0
0682-0053-142020-09-25C16284748780-1ab0e2407-353c-f274-e053-dbdaa90a64719c06b971-8621-4235-ae27-36184c22a6e0
0682-0053-302020-09-25C16284748780-1ab0e2407-353c-f274-e053-dbdaa90a64719c06b971-8621-4235-ae27-36184c22a6e0
0682-0053-142020-07-22C16284748780-1ab0e2407-353c-f274-e053-dbdaa90a64719c06b971-8621-4235-ae27-36184c22a6e0
0682-0053-302020-07-22C16284748780-1ab0e2407-353c-f274-e053-dbdaa90a64719c06b971-8621-4235-ae27-36184c22a6e0

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0682-0053-30EA - Each0682-0053f6b54342-d228-41ba-9093-9cce99634d3612018-09-05