Adapalene

Product NDC
0363-1401
11-digit product format
003631401
Labeler code
0363
Product ID
0363-1401_b91f4c74-1570-4403-a576-6e59bea286ed
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
Walgreens
Application
ANDA090962
Marketing category
ANDA
Marketing start
2023-10-25
Substance
ADAPALENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
1L4806J2QFADAPALENE106685-40-9ADAPALENE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-1401-05003631401051 TUBE in 1 CARTON (0363-1401-05) / 15 g in 1 TUBE1 tube2023-10-25NoNoHistorical
0363-1401-16003631401161 TUBE in 1 CARTON (0363-1401-16) / 45 g in 1 TUBE1 tube2023-10-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Adapalene Gel USP 0 1 percent ozWalgreens2025-03-12HUMAN OTC DRUG LABEL5