FDA.reportPublic FDA data

Triazolam

Product NDC
50742-646
11-digit product format
507420646
Labeler code
50742
Product ID
50742-646_22a3bdbc-8edf-45a5-ad5c-4a0c3f73f255
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triazolam
Dosage form
TABLET
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA214219
Marketing category
ANDA
Marketing start
2020-10-20
Substance
TRIAZOLAM
Active strength
.25 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Triazolam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAZOLAM.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1HM943223R
Rxcui198317, 198318

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
50ba0308-e38d-ba7a-26f9-ab61326900c2Product name420240208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-646-01Triazolam100 in 1 BOTTLE, PLASTICTABLET1007
50742-646-05Triazolam500 in 1 BOTTLE, PLASTICTABLET5007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-646TRIAZOLAM TABLET [INGENUS PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 2 package rows20230627_a0c99f0b-4122-4611-9b53-80fadfceacb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198318triazolam 0.25 MG Oral TabletPSN5fccc31d-32c9-49e7-91a9-664cc726872b103
198318triazolam 0.25 MG Oral TabletSCD5fccc31d-32c9-49e7-91a9-664cc726872b103
198318triazolam 0.25 MG Oral TabletPSNf8ca4773-e201-4cb9-8869-5ee07ba1d0bf10
198318triazolam 0.25 MG Oral TabletSCDf8ca4773-e201-4cb9-8869-5ee07ba1d0bf10
198317triazolam 0.125 MG Oral TabletPSNa0c99f0b-4122-4611-9b53-80fadfceacb67
198318triazolam 0.25 MG Oral TabletPSNa0c99f0b-4122-4611-9b53-80fadfceacb67
198317triazolam 0.125 MG Oral TabletSCDa0c99f0b-4122-4611-9b53-80fadfceacb67
198318triazolam 0.25 MG Oral TabletSCDa0c99f0b-4122-4611-9b53-80fadfceacb67
198318triazolam 0.25 MG Oral TabletPSN5a330f08-5d8f-4f8d-8847-a45b734412b41
198318triazolam 0.25 MG Oral TabletPSNba1d8955-41f8-4b4d-8ed8-e92667e294a11
198318triazolam 0.25 MG Oral TabletSCD5a330f08-5d8f-4f8d-8847-a45b734412b41
198318triazolam 0.25 MG Oral TabletSCDba1d8955-41f8-4b4d-8ed8-e92667e294a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-646-0150742064601100 TABLET in 1 BOTTLE, PLASTIC (50742-646-01) 100 tablet2020-10-200000-00-00NoNoCurrent
50742-646-0550742064605500 TABLET in 1 BOTTLE, PLASTIC (50742-646-05) 500 tablet2020-10-200000-00-00NoNoCurrent