TRETINOIN

Product NDC
68071-3945
11-digit product format
680713945
Labeler code
68071
Product ID
68071-3945_47fc44a9-f3ed-a612-e063-6394a90a16f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA075264
Marketing category
ANDA
Marketing start
2017-06-15
Substance
TRETINOIN
Active strength
.25 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRETINOIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN.25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui106302

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3945-2TRETINOIN1 in 1 CARTONCREAM11
68071-3945-2TRETINOIN20 g in 1 TUBECREAM201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3945-2680713945021 TUBE in 1 CARTON (68071-3945-2) / 20 g in 1 TUBE1 tube2026-01-09NoNoHistorical