TRETINOIN

Product NDC
68788-4069
11-digit product format
687884069
Labeler code
68788
Product ID
68788-4069_d6819051-4748-479e-8b53-c298edcbd410
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075264
Marketing category
ANDA
Marketing start
2026-01-28
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-4069-2TRETINOIN1 in 1 CARTONCREAM11
68788-4069-2TRETINOIN20 g in 1 TUBECREAM201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4069-2GM - Gram68788-40696b839ffd-b2e9-46d3-9112-7a4c5d04e8c912026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSNd6819051-4748-479e-8b53-c298edcbd4101
106302tretinoin 0.25 MG/ML Topical CreamSCDd6819051-4748-479e-8b53-c298edcbd4101
106302tretinoin 0.025 % Topical CreamSYd6819051-4748-479e-8b53-c298edcbd4101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4069-2687884069021 TUBE in 1 CARTON (68788-4069-2) / 20 g in 1 TUBE1 tube2026-01-28NoNoHistorical