FDA.reportPublic FDA data

TRETINOIN

Product NDC
72162-2135
11-digit product format
721622135
Labeler code
72162
Product ID
72162-2135_5e84c976-d4d6-4d8f-a448-8afb47e2fbff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA075264
Marketing category
ANDA
Marketing start
2017-06-15
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
72162-2135-2TRETINOIN20 g in 1 TUBECREAM20102
72162-2135-2TRETINOIN1 in 1 CARTONCREAM1102
72162-2135-4TRETINOIN45 g in 1 TUBECREAM45102
72162-2135-4TRETINOIN1 in 1 CARTONCREAM1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2135-2GM - Gram72162-2135f4afee14-78ee-44a5-a4a7-1711963b977212023-10-16
72162-2135-4GM - Gram72162-21350cff6dc0-e306-4714-b67e-baf324c9133d12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2135TRETINOIN CREAM [BRYANT RANCH PREPACK]102Current NDC, 4 package rows20240406_5e84c976-d4d6-4d8f-a448-8afb47e2fbff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSN5e84c976-d4d6-4d8f-a448-8afb47e2fbff102
106302tretinoin 0.25 MG/ML Topical CreamSCD5e84c976-d4d6-4d8f-a448-8afb47e2fbff102
106302tretinoin 0.025 % Topical CreamSY5e84c976-d4d6-4d8f-a448-8afb47e2fbff102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2135-2721622135021 TUBE in 1 CARTON (72162-2135-2) / 20 g in 1 TUBE1 tube2017-06-15NoNoCurrent
72162-2135-4721622135041 TUBE in 1 CARTON (72162-2135-4) / 45 g in 1 TUBE1 tube2017-06-15NoNoCurrent