FDA.reportPublic FDA data

Halcion

Product NDC
0009-0017
11-digit product format
000090017
Labeler code
0009
Product ID
0009-0017_632e2836-1da3-4c6d-a954-e452580587e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triazolam
Dosage form
TABLET
Route
ORAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA017892
Marketing category
NDA
Marketing start
1982-11-15
Marketing end
2026-06-30
Substance
TRIAZOLAM
Active strength
.25 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Halcion

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAZOLAM.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1HM943223R

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
0009-0017-55Halcion1 in 1 BLISTER PACKTABLET133
0009-0017-55Halcion100 in 1 CARTONTABLET10033
0009-0017-58Halcion10 in 1 BOTTLETABLET1033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0017-55EA - Each0009-001720920f7b-7c55-4027-a5b8-ca695c34d49512012-07-24
0009-0017-58EA - Each0009-0017ac80888d-1a26-4362-a670-9d80ee13620e12014-01-04
0009-0017-59EA - Each0009-0017f2a7c478-3d3b-4983-aba0-80fadbce016d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAZOLAMACTIVE INGREDIENT1HM943223RHALCION (TRIAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]13
TRIAZOLAMACTIVE MOIETY1HM943223RHALCION (TRIAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]13
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0HALCION (TRIAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]13
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHALCION (TRIAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]13
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GHALCION (TRIAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HALCION (TRIAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]13
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MHALCION (TRIAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HALCION (TRIAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]13
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHALCION (TRIAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHALCION (TRIAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0017HALCION (TRIAZOLAM) TABLET [PHARMACIA & UPJOHN COMPANY LLC]31Current NDC, Legacy NDC, 3 package rows20250110_a0da0dba-a56d-486b-a45b-e8a7cdfbeac6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208681Halcion 0.25 MG Oral TabletPSNa0da0dba-a56d-486b-a45b-e8a7cdfbeac633
198318triazolam 0.25 MG Oral TabletPSNa0da0dba-a56d-486b-a45b-e8a7cdfbeac633
208681triazolam 0.25 MG Oral Tablet [Halcion]SBDa0da0dba-a56d-486b-a45b-e8a7cdfbeac633
198318triazolam 0.25 MG Oral TabletSCDa0da0dba-a56d-486b-a45b-e8a7cdfbeac633
208681Halcion 0.25 MG Oral TabletSYa0da0dba-a56d-486b-a45b-e8a7cdfbeac633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0017-5500009001755100 BLISTER PACK in 1 CARTON (0009-0017-55) / 1 TABLET in 1 BLISTER PACK100 blister pack1982-11-152026-06-30NoNoCurrent
0009-0017-580000900175810 TABLET in 1 BOTTLE (0009-0017-58) 10 tablet1982-11-150000-00-00NoNoCurrent