FDA.reportPublic FDA data

TRETINOIN

Product NDC
21922-057
11-digit product format
219220057
Labeler code
21922
Product ID
21922-057_09404f33-7d64-49aa-831d-7bb2e2fe3c9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA217587
Marketing category
ANDA
Marketing start
2025-03-06
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
Rxcui313450, 313451

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
21922-057-04TRETINOIN15 g in 1 TUBEGEL154
21922-057-04TRETINOIN1 in 1 CARTONGEL14
21922-057-06TRETINOIN45 g in 1 TUBEGEL454
21922-057-06TRETINOIN1 in 1 CARTONGEL14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-057-04GM - Gram21922-05792b6db0a-abdf-4d26-af6d-d190dac7a66412025-06-13
21922-057-06GM - Gram21922-057e3a1631a-1752-4fe6-bc5f-d83f38f4908a12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-057TRETINOIN GEL [ENCUBE ETHICALS PRIVATE LIMITED]3Current NDC, 4 package rows20250308_b61f6b02-6171-4da8-94eb-bcd4808dd918.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313450tretinoin 0.01 % Topical GelPSNb61f6b02-6171-4da8-94eb-bcd4808dd9184
313451tretinoin 0.025 % Topical GelPSNb61f6b02-6171-4da8-94eb-bcd4808dd9184
313450tretinoin 0.0001 MG/MG Topical GelSCDb61f6b02-6171-4da8-94eb-bcd4808dd9184
313451tretinoin 0.00025 MG/MG Topical GelSCDb61f6b02-6171-4da8-94eb-bcd4808dd9184
313450tretinoin 0.01 % Topical GelSYb61f6b02-6171-4da8-94eb-bcd4808dd9184
313451tretinoin 0.025 % Topical GelSYb61f6b02-6171-4da8-94eb-bcd4808dd9184

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-057-04219220057041 TUBE in 1 CARTON (21922-057-04) / 15 g in 1 TUBE1 tube2025-03-06NoNoCurrent
21922-057-06219220057061 TUBE in 1 CARTON (21922-057-06) / 45 g in 1 TUBE1 tube2025-03-06NoNoCurrent