TRETINOIN

Product NDC
0574-2201
11-digit product format
005742201
Labeler code
0574
Product ID
0574-2201_a25193b8-414f-4dfc-8ddc-8c5f92758279
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis US LLC
Application
ANDA075213
Marketing category
ANDA
Marketing start
2017-03-30
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
Rxcui106302, 106303, 198300, 313450, 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
0574-2201-20TRETINOIN1 in 1 CARTONCREAM118
0574-2201-20TRETINOIN20 g in 1 TUBECREAM2018
0574-2201-45TRETINOIN45 g in 1 TUBECREAM4518
0574-2201-45TRETINOIN1 in 1 CARTONCREAM118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-2201-20GM - Gram0574-2201cf97b518-7fc0-4f06-a77e-f699ec475c9312017-05-03
0574-2201-45GM - Gram0574-2201c9769e0e-4780-4c0b-ae15-a374cc9e5d4912017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-2201TRETINOIN GEL TRETINOIN CREAM [PADAGIS US LLC]18Current NDC, Legacy NDC, 4 package rows20250202_4889c7f8-37d0-4f1a-9829-bca107806586.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSN0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106303tretinoin 0.05 % Topical CreamPSN0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
198300tretinoin 0.1 % Topical CreamPSN0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106302tretinoin 0.25 MG/ML Topical CreamSCD0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106303tretinoin 0.5 MG/ML Topical CreamSCD0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
198300tretinoin 1 MG/ML Topical CreamSCD0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106302tretinoin 0.025 % Topical CreamSY0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
106303tretinoin 0.05 % Topical CreamSY0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
198300tretinoin 0.1 % Topical CreamSY0a6722ba-c2e5-4d7a-82ea-bcd6a54033b524
313450tretinoin 0.01 % Topical GelPSN4889c7f8-37d0-4f1a-9829-bca10780658618
106302tretinoin 0.025 % Topical CreamPSN4889c7f8-37d0-4f1a-9829-bca10780658618
313451tretinoin 0.025 % Topical GelPSN4889c7f8-37d0-4f1a-9829-bca10780658618
106303tretinoin 0.05 % Topical CreamPSN4889c7f8-37d0-4f1a-9829-bca10780658618
198300tretinoin 0.1 % Topical CreamPSN4889c7f8-37d0-4f1a-9829-bca10780658618
313450tretinoin 0.0001 MG/MG Topical GelSCD4889c7f8-37d0-4f1a-9829-bca10780658618
313451tretinoin 0.00025 MG/MG Topical GelSCD4889c7f8-37d0-4f1a-9829-bca10780658618
106302tretinoin 0.25 MG/ML Topical CreamSCD4889c7f8-37d0-4f1a-9829-bca10780658618
106303tretinoin 0.5 MG/ML Topical CreamSCD4889c7f8-37d0-4f1a-9829-bca10780658618
198300tretinoin 1 MG/ML Topical CreamSCD4889c7f8-37d0-4f1a-9829-bca10780658618
313450tretinoin 0.01 % Topical GelSY4889c7f8-37d0-4f1a-9829-bca10780658618
106302tretinoin 0.025 % Topical CreamSY4889c7f8-37d0-4f1a-9829-bca10780658618
313451tretinoin 0.025 % Topical GelSY4889c7f8-37d0-4f1a-9829-bca10780658618
106303tretinoin 0.05 % Topical CreamSY4889c7f8-37d0-4f1a-9829-bca10780658618
198300tretinoin 0.1 % Topical CreamSY4889c7f8-37d0-4f1a-9829-bca10780658618
198300tretinoin 0.1 % Topical CreamPSNc4d5155b-046d-4f94-bafc-651b572c2bd58
198300tretinoin 1 MG/ML Topical CreamSCDc4d5155b-046d-4f94-bafc-651b572c2bd58
198300tretinoin 0.1 % Topical CreamSYc4d5155b-046d-4f94-bafc-651b572c2bd58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-2201-20005742201201 TUBE in 1 CARTON (0574-2201-20) / 20 g in 1 TUBE1 tube2017-03-300000-00-00NoNoCurrent
0574-2201-45005742201451 TUBE in 1 CARTON (0574-2201-45) / 45 g in 1 TUBE1 tube2017-04-170000-00-00NoNoCurrent