Tretinoin

Product NDC
68462-792
11-digit product format
684620792
Labeler code
68462
Product ID
68462-792_5761f729-3e1f-4fe7-9d5f-cfb652bf1625
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA208279
Marketing category
ANDA
Marketing start
2016-12-23
Substance
TRETINOIN
Active strength
10 mg/1
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-792-01Tretinoin100 in 1 BOTTLECAPSULE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-792-01EA - Each68462-792474846b6-fb06-4da3-8582-f51ddc54546d12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-792TRETINOIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4Current NDC, Legacy NDC, 1 package rows20230425_264138c1-9e5f-45ef-be87-79ca97c989d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199159tretinoin 10 MG Oral CapsulePSN264138c1-9e5f-45ef-be87-79ca97c989d96
199159tretinoin 10 MG Oral CapsuleSCD264138c1-9e5f-45ef-be87-79ca97c989d96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-792-0168462079201100 CAPSULE in 1 BOTTLE (68462-792-01) 100 capsule2016-12-230000-00-00NoNoCurrent