Tretinoin

Product NDC
59651-713
11-digit product format
596510713
Labeler code
59651
Product ID
59651-713_50b05c90-bdd9-4766-b285-52bd88c4c740
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218245
Marketing category
ANDA
Marketing start
2025-02-27
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
Rxcui313451

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
59651-713-14Tretinoin15 g in 1 TUBEGEL153
59651-713-14Tretinoin1 in 1 CARTONGEL13
59651-713-46Tretinoin45 g in 1 TUBEGEL453
59651-713-46Tretinoin1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-713TRETINOIN GEL [AUROBINDO PHARMA LIMITED]2Current NDC, 4 package rows20250408_dea325b5-3cb8-4ffb-84e9-782f0e3f6b0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313451tretinoin 0.025 % Topical GelPSNdea325b5-3cb8-4ffb-84e9-782f0e3f6b0e3
313451tretinoin 0.00025 MG/MG Topical GelSCDdea325b5-3cb8-4ffb-84e9-782f0e3f6b0e3
313451tretinoin 0.025 % Topical GelSYdea325b5-3cb8-4ffb-84e9-782f0e3f6b0e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-713-14596510713141 TUBE in 1 CARTON (59651-713-14) / 15 g in 1 TUBE1 tube2025-02-27NoNoCurrent
59651-713-46596510713461 TUBE in 1 CARTON (59651-713-46) / 45 g in 1 TUBE1 tube2025-02-27NoNoCurrent