Tretinoin

Product NDC
72162-2303
11-digit product format
721622303
Labeler code
72162
Product ID
72162-2303_d4a78cfd-7499-4e65-9c01-e97fa7545caa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA215609
Marketing category
ANDA
Marketing start
2023-08-24
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
72162-2303-2Tretinoin1 in 1 CARTONGEL1101
72162-2303-2Tretinoin50 g in 1 BOTTLE, PUMPGEL50101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2303-2GM - Gram72162-23036dd46494-979e-46bf-a1c3-7fb805a74d0812024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2303TRETINOIN GEL [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20240502_2b58cf56-e713-4cdd-8b4e-e6651ef76650.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488045tretinoin 0.08 % Topical GelPSN2b58cf56-e713-4cdd-8b4e-e6651ef76650101
1488045tretinoin 0.0008 MG/MG Topical GelSCD2b58cf56-e713-4cdd-8b4e-e6651ef76650101
1488045tretinoin 0.08 % Topical GelSY2b58cf56-e713-4cdd-8b4e-e6651ef76650101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2303-2721622303021 BOTTLE, PUMP in 1 CARTON (72162-2303-2) / 50 g in 1 BOTTLE, PUMP2024-04-30NoNoHistorical