Tretinoin

Product NDC
68071-3865
11-digit product format
680713865
Labeler code
68071
Product ID
68071-3865_373dda8f-0dcc-4554-e063-6394a90ad5eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA211644
Marketing category
ANDA
Marketing start
2019-01-25
Substance
TRETINOIN
Active strength
.5 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
5688UTC01RTRETINOIN302-79-4TRETINOIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3865-2680713865021 TUBE in 1 CARTON (68071-3865-2) / 20 g in 1 TUBE1 tube2025-06-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tretinoin Cream USP, 0.05%NuCare Pharmaceuticals,Inc.2025-06-10HUMAN PRESCRIPTION DRUG LABEL1