Tretinoin

Product NDC
46708-809
11-digit product format
467080809
Labeler code
46708
Product ID
46708-809_dc155719-fc32-4f08-a9db-b59da2f80759
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA218399
Marketing category
ANDA
Marketing start
2025-08-16
Substance
TRETINOIN
Active strength
.25 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
46708-809-20467080809201 TUBE in 1 CARTON (46708-809-20) / 20 g in 1 TUBE1 tube2025-08-16NoNoHistorical
46708-809-45467080809451 TUBE in 1 CARTON (46708-809-45) / 45 g in 1 TUBE1 tube2025-08-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tretinoin Cream USP, 0.025% For Topical Use OnlyAlembic Pharmaceuticals Limited2025-09-16HUMAN PRESCRIPTION DRUG LABEL1