Tretinoin

Product NDC
59651-712
11-digit product format
596510712
Labeler code
59651
Product ID
59651-712_11e769a1-681a-4367-a0b6-a08ff62157f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218246
Marketing category
ANDA
Marketing start
2025-01-13
Substance
TRETINOIN
Active strength
.1 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.1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui313450

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
59651-712-14Tretinoin1 in 1 CARTONGEL13
59651-712-14Tretinoin15 g in 1 TUBEGEL153
59651-712-46Tretinoin1 in 1 CARTONGEL13
59651-712-46Tretinoin45 g in 1 TUBEGEL453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-712-14GM - Gram59651-712603756b5-60ac-49e8-89f2-e525524a6bc012026-02-05
59651-712-46GM - Gram59651-71233f67a51-727e-4051-b502-e9b286ab7db112026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-712TRETINOIN GEL [AUROBINDO PHARMA LIMITED]2Current NDC, 4 package rows20250223_f64e45d7-bbc0-4da4-9ccb-e3941f22fdbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313450tretinoin 0.01 % Topical GelPSNf64e45d7-bbc0-4da4-9ccb-e3941f22fdbe3
313450tretinoin 0.0001 MG/MG Topical GelSCDf64e45d7-bbc0-4da4-9ccb-e3941f22fdbe3
313450tretinoin 0.01 % Topical GelSYf64e45d7-bbc0-4da4-9ccb-e3941f22fdbe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-712-14596510712141 TUBE in 1 CARTON (59651-712-14) / 15 g in 1 TUBE1 tube2025-01-13NoNoHistorical
59651-712-46596510712461 TUBE in 1 CARTON (59651-712-46) / 45 g in 1 TUBE1 tube2025-01-13NoNoHistorical