Tretinoin

Product NDC
71335-2952
11-digit product format
713352952
Labeler code
71335
Product ID
71335-2952_8f5850a4-4294-418c-8b1f-65f229e5973f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
NDA017955
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-08-12
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

openFDA Listing Details

Product ID
71335-2952_8f5850a4-4294-418c-8b1f-65f229e5973f
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Tretinoin
Generic name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Marketing start
2019-08-12
Marketing category
NDA AUTHORIZED GENERIC
Application number
NDA017955
Pharmacologic classes
Retinoid [EPC]; Retinoids [CS]
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
TRETINOIN.1 mg/g

openFDA Harmonized Identifiers

FieldValues
Unii5688UTC01R
Rxcui313450
Spl Set Id04f14d6e-5b44-44bd-a7f3-d684d9c5d7cb
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
5688UTC01RTRETINOIN302-79-4TRETINOIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2952-1713352952011 TUBE in 1 CARTON (71335-2952-1) / 45 g in 1 TUBE1 tube2025-10-21NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TRETINOIN CREAM – TRETINOIN GELBryant Ranch Prepack2025-10-21HUMAN PRESCRIPTION DRUG LABEL100