FDA.reportPublic FDA data

Tretinoin

Product NDC
72578-153
11-digit product format
725780153
Labeler code
72578
Product ID
72578-153_97ba2e16-fc52-495e-bc88-84f93170ca07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA218561
Marketing category
ANDA
Marketing start
2024-04-30
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
TRETINOIN1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui198300

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
72578-153-08Tretinoin45 g in 1 TUBECREAM451
72578-153-08Tretinoin1 in 1 CARTONCREAM11
72578-153-09Tretinoin20 g in 1 TUBECREAM201
72578-153-09Tretinoin1 in 1 CARTONCREAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-153-08GM - Gram72578-153cdd4023e-6eeb-46f5-9345-9cd7543dd01312025-02-10
72578-153-09GM - Gram72578-153ee9c33ec-8207-4077-8bf6-adbaf663b8a312025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-153TRETINOIN CREAM [VIONA PHARMACEUTICALS INC]1Current NDC, 4 package rows20240501_2ee7844c-e5ee-4d15-80c7-c07a9f23ccdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198300tretinoin 0.1 % Topical CreamPSN2ee7844c-e5ee-4d15-80c7-c07a9f23ccdd1
198300tretinoin 1 MG/ML Topical CreamSCD2ee7844c-e5ee-4d15-80c7-c07a9f23ccdd1
198300tretinoin 0.1 % Topical CreamSY2ee7844c-e5ee-4d15-80c7-c07a9f23ccdd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72578-153-08725780153081 TUBE in 1 CARTON (72578-153-08) / 45 g in 1 TUBE1 tube2024-04-30NoNoCurrent
72578-153-09725780153091 TUBE in 1 CARTON (72578-153-09) / 20 g in 1 TUBE1 tube2024-04-30NoNoCurrent