Tretinoin

Product NDC
0904-6867
11-digit product format
009046867
Labeler code
0904
Product ID
0904-6867_84e260ff-4ef4-483e-af99-8923b69f66df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA201687
Marketing category
ANDA
Marketing start
2012-10-24
Substance
TRETINOIN
Active strength
10 mg/1
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui199159

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
0904-6867-04Tretinoin1 in 1 BLISTER PACKCAPSULE18
0904-6867-04Tretinoin30 in 1 CARTONCAPSULE308
0904-6867-60Tretinoin100 in 1 BOTTLECAPSULE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6867-04EA - Each0904-6867d436f9f7-f7e4-4a92-88be-641007b8868712019-08-06
0904-6867-60EA - Each0904-68670fa22680-e4fd-46b0-850f-38bf3412a1e712019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6867TRETINOIN CAPSULE [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 3 package rows20250424_045258e2-5efb-4147-bf74-4c43af04dccc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199159tretinoin 10 MG Oral CapsulePSN045258e2-5efb-4147-bf74-4c43af04dccc8
199159tretinoin 10 MG Oral CapsuleSCD045258e2-5efb-4147-bf74-4c43af04dccc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6867-040090468670430 BLISTER PACK in 1 CARTON (0904-6867-04) / 1 CAPSULE in 1 BLISTER PACK30 blister pack2012-10-240000-00-00NoNoCurrent
0904-6867-6000904686760100 CAPSULE in 1 BOTTLE (0904-6867-60) 100 capsule2012-10-242022-11-30NoNoCurrent