Tretinoin

Product NDC
0378-8092
11-digit product format
003788092
Labeler code
0378
Product ID
0378-8092_c9f92ca9-5c8e-4a76-9304-a92bc552246b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA020475
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-08-12
Marketing end
0000-00-00
Substance
TRETINOIN
Active strength
0 mg/g
Pharmacologic classes
Retinoid [EPC],Retinoids [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-8092-20GM - Gram0378-80925544db9e-ed70-4de1-8193-d0cb8e4fcfb512019-09-05
0378-8092-45GM - Gram0378-8092c8cdfbe2-0e36-4aaa-8b02-1f310d868c3a12019-09-05
0378-8092-50GM - Gram0378-8092cd8ecc70-932a-40de-82bf-9781357b90d812019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-8092TRETINOIN GEL [MYLAN PHARMACEUTICALS INC.]9Legacy NDC20240824_ff10a007-5814-4794-8ce3-da5cc85fca85.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-8092-20003788092201 TUBE in 1 CARTON (0378-8092-20) > 20 g in 1 TUBE1 tube2019-08-260000-00-00NoNoCurrent
0378-8092-45003788092451 TUBE in 1 CARTON (0378-8092-45) > 45 g in 1 TUBE1 tube2019-08-260000-00-00NoNoCurrent
0378-8092-50003788092501 BOTTLE, PUMP in 1 CARTON (0378-8092-50) > 50 g in 1 BOTTLE, PUMP2019-08-120000-00-00NoNoCurrent