Tretinoin

Product NDC
68788-8857
11-digit product format
687888857
Labeler code
68788
Product ID
68788-8857_fda88f47-21b3-4678-ab21-befb03035730
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA215713
Marketing category
ANDA
Marketing start
2025-04-11
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

Additional Listing Data#

Finished product
Yes
Brand name base
Tretinoin
Listing expiration
2026-12-31

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
68788-8857-2Tretinoin20 g in 1 TUBECREAM201
68788-8857-2Tretinoin1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8857-2GM - Gram68788-88571b57971e-7859-40eb-b9f9-1b767f1a4f5012025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8857TRETINOIN CREAM [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20250413_fda88f47-21b3-4678-ab21-befb03035730.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSNfda88f47-21b3-4678-ab21-befb030357301
106302tretinoin 0.25 MG/ML Topical CreamSCDfda88f47-21b3-4678-ab21-befb030357301
106302tretinoin 0.025 % Topical CreamSYfda88f47-21b3-4678-ab21-befb030357301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8857-2687888857021 TUBE in 1 CARTON (68788-8857-2) / 20 g in 1 TUBE1 tube2025-04-11NoNoHistorical