Tretinoin

Product NDC
46708-807
11-digit product format
467080807
Labeler code
46708
Product ID
46708-807_f46af408-0e68-4a78-8928-fc655c54d0c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA217804
Marketing category
ANDA
Marketing start
2025-04-25
Substance
TRETINOIN
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
5688UTC01RTRETINOIN302-79-4TRETINOIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-807-20467080807201 TUBE in 1 CARTON (46708-807-20) / 20 g in 1 TUBE1 tube2025-04-25NoNoHistorical
46708-807-45467080807451 TUBE in 1 CARTON (46708-807-45) / 45 g in 1 TUBE1 tube2025-04-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tretinoin Cream USP, 0.1% For Topical Use OnlyAlembic Pharmaceuticals Limited2025-04-25HUMAN PRESCRIPTION DRUG LABEL1