Tretinoin

Product NDC
68084-075
11-digit product format
680840075
Labeler code
68084
Product ID
68084-075_41c2a834-9f5a-9820-e063-6294a90ad914
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA201687
Marketing category
ANDA
Marketing start
2013-07-18
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
2026-12-31

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
68084-075-11Tretinoin10 in 1 BLISTER PACKCAPSULE107
68084-075-21Tretinoin3 in 1 CARTONCAPSULE37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-075-11EA - Each68084-0755dc9d210-c8a6-4333-bdd7-5b90db00784512013-08-02
68084-075-21EA - Each68084-0759b2d182f-b0c2-45cf-a3ca-2ce81b956b5e12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRETINOINACTIVE INGREDIENT5688UTC01RTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
TRETINOINACTIVE MOIETY5688UTC01RTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
GELATININACTIVE INGREDIENT2G86QN327LTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
NITROGENINACTIVE INGREDIENTN762921K75TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177ATRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
WATERINACTIVE INGREDIENT059QF0KO0RTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VTRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-075TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20241031_b22d5a07-623a-4645-b87d-a151b86da8d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199159tretinoin 10 MG Oral CapsulePSNb22d5a07-623a-4645-b87d-a151b86da8d57
199159tretinoin 10 MG Oral CapsuleSCDb22d5a07-623a-4645-b87d-a151b86da8d57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-075-116808400751110 in 1 BLISTER PACKHistorical
68084-075-21680840075213 BLISTER PACK in 1 CARTON (68084-075-21) / 10 CAPSULE in 1 BLISTER PACK (68084-075-11) 3 blister pack2013-07-180000-00-00NoNoCurrent