Tretinoin

Product NDC
69238-2323
11-digit product format
692382323
Labeler code
69238
Product ID
69238-2323_4d764131-27ac-47d1-971b-849368e94e6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA217497
Marketing category
ANDA
Marketing start
2026-05-15
Substance
TRETINOIN
Active strength
.8 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.8 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui1488045

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2323-1Tretinoin1 in 1 CARTONGEL17
69238-2323-1Tretinoin50 g in 1 BOTTLE, PUMPGEL507

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488045tretinoin 0.08 % Topical GelPSN4b6006e3-f7a4-4823-8217-3e5b0f7e58d97
1488045tretinoin 0.0008 MG/MG Topical GelSCD4b6006e3-f7a4-4823-8217-3e5b0f7e58d97
1488045tretinoin 0.08 % Topical GelSY4b6006e3-f7a4-4823-8217-3e5b0f7e58d97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69238-2323-1692382323011 BOTTLE, PUMP in 1 CARTON (69238-2323-1) / 50 g in 1 BOTTLE, PUMP2026-05-15NoNoCurrent