FDA.reportPublic FDA data

Tretinoin

Product NDC
0472-0117
11-digit product format
004720117
Labeler code
0472
Product ID
0472-0117_b99bedbe-3d36-47dd-b84c-05f8bb394b83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
NDA020404
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1998-04-20
Marketing end
2027-07-31
Substance
TRETINOIN
Active strength
.25 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tretinoin

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
0472-0117-20Tretinoin1 in 1 CARTONCREAM116
0472-0117-20Tretinoin20 g in 1 TUBECREAM2016
0472-0117-45Tretinoin1 in 1 CARTONCREAM116
0472-0117-45Tretinoin45 g in 1 TUBECREAM4516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0117-20GM - Gram0472-0117fffa3905-688e-4091-bc1a-3795b207ca3f12013-02-13
0472-0117-45GM - Gram0472-01170a078fb6-8e59-4f24-859d-9d054fd43ad312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRETINOINACTIVE INGREDIENT5688UTC01RTRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]3
TRETINOINACTIVE MOIETY5688UTC01RTRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]3
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]3
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ITRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]3
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]3
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RTRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETRETINOIN CREAM [ACTAVIS MID ATLANTIC LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0117TRETINOIN CREAM [ACTAVIS PHARMA, INC.]16Current NDC, Legacy NDC, 4 package rows20250403_b5e385a2-f6f9-41cb-8a33-eedba397043f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSNc7860dcd-91b0-44e0-98d6-a843b16457e119
106302tretinoin 0.25 MG/ML Topical CreamSCDc7860dcd-91b0-44e0-98d6-a843b16457e119
106302tretinoin 0.025 % Topical CreamSYc7860dcd-91b0-44e0-98d6-a843b16457e119
106302tretinoin 0.025 % Topical CreamPSNb5e385a2-f6f9-41cb-8a33-eedba397043f16
106302tretinoin 0.25 MG/ML Topical CreamSCDb5e385a2-f6f9-41cb-8a33-eedba397043f16
106302tretinoin 0.025 % Topical CreamSYb5e385a2-f6f9-41cb-8a33-eedba397043f16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0117-20004720117201 TUBE in 1 CARTON (0472-0117-20) / 20 g in 1 TUBE1 tube1998-04-202027-07-31NoNoCurrent
0472-0117-45004720117451 TUBE in 1 CARTON (0472-0117-45) / 45 g in 1 TUBE1 tube1998-04-202027-07-31NoNoCurrent