FDA.reportPublic FDA data

Tretinoin

Product NDC
62332-807
11-digit product format
623320807
Labeler code
62332
Product ID
62332-807_8fdbeffa-453b-4e17-86ba-e249bcf8544c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA217804
Marketing category
ANDA
Marketing start
2024-05-01
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
62332-807-20Tretinoin20 g in 1 TUBECREAM203
62332-807-20Tretinoin1 in 1 CARTONCREAM13
62332-807-45Tretinoin45 g in 1 TUBECREAM453
62332-807-45Tretinoin1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-807-20GM - Gram62332-8070b279a20-a763-46e4-b180-04831c9f1dde12024-07-12
62332-807-45GM - Gram62332-807da9b1569-4801-45cc-9883-e2d2a3c7f0be12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-807TRETINOIN CREAM [ALEMBIC PHARMACEUTICALS INC.]3Current NDC, 4 package rows20240502_d6cc176c-ca71-481b-93c4-36565770a7b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198300tretinoin 0.1 % Topical CreamPSNd6cc176c-ca71-481b-93c4-36565770a7b53
198300tretinoin 1 MG/ML Topical CreamSCDd6cc176c-ca71-481b-93c4-36565770a7b53
198300tretinoin 0.1 % Topical CreamSYd6cc176c-ca71-481b-93c4-36565770a7b53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-807-20623320807201 TUBE in 1 CARTON (62332-807-20) / 20 g in 1 TUBE1 tube2024-05-01NoNoCurrent
62332-807-45623320807451 TUBE in 1 CARTON (62332-807-45) / 45 g in 1 TUBE1 tube2024-05-01NoNoCurrent