Triazolam

Product NDC
43353-451
11-digit product format
433530451
Labeler code
43353
Product ID
43353-451_fe714ed3-35c9-4c0c-b64c-d6e1ba0e685f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triazolam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA017892
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1982-11-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017892-001HALCIONTRIAZOLAM0.25MGTABLET / ORALABRLD, RS1982-11-15
N017892-002HALCIONTRIAZOLAM0.5MGTABLET / ORAL1982-11-15
N017892-003HALCIONTRIAZOLAM0.125MGTABLET / ORALABRLD1985-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N017892-001AB
N017892-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-15caaa826d4ba7…
2026-08-18 06:07:402026-07N017892-002HALCION0.5MGTABLET / ORAL1982-11-15caaa826d4ba7…
2026-08-18 06:07:402026-07N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017892-002HALCION0.5MGTABLET / ORAL1982-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017892-002HALCION0.5MGTABLET / ORAL1982-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017892-002HALCION0.5MGTABLET / ORAL1982-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017892-002HALCION0.5MGTABLET / ORAL1982-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017892-002HALCION0.5MGTABLET / ORAL1982-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017892-002HALCION0.5MGTABLET / ORAL1982-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017892-002HALCION0.5MGTABLET / ORAL1982-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017892-002HALCION0.5MGTABLET / ORAL1982-11-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017892-002HALCION0.5MGTABLET / ORAL1982-11-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N017892-002HALCION0.5MGTABLET / ORAL1982-11-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017892-002HALCION0.5MGTABLET / ORAL1982-11-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017892-002HALCION0.5MGTABLET / ORAL1982-11-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017892-003HALCION0.125MGTABLET / ORALABRLD1985-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017892-001HALCION0.25MGTABLET / ORALABRLD, RS1982-11-151e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N017892-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N017892-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017892-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017892-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017892-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017892-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017892-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017892-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017892-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017892-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017892-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017892-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017892-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017892-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017892-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017892-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017892-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017892-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017892-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017892-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017892-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017892-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017892-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017892-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017892-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017892-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017892-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017892-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017892-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017892-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017892-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017892-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017892-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017892-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017892-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017892-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017892-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017892-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017892-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N017892-003AB1bb7c543d1eb4…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1HM943223RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198318Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
97164a9c-4bc7-4f15-829e-5f9e653c7fa5Available on FDA.report

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
43353-451-30Triazolam30 in 1 BOTTLETABLET301
43353-451-53Triazolam60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-451-30EA - Each43353-45148623e45-6ff5-405a-8e3a-a1780ddc722212017-12-14
43353-451-53EA - Each43353-4519231c10a-b948-4b29-8d01-180ba57e752912017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-451TRIAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20171117_97164a9c-4bc7-4f15-829e-5f9e653c7fa5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TriazolamTRIAZOLAMMylan Pharmaceuticals Inc.5add318e-11b9-42f8-b052-0d8cebb32fcf2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 017892
application number: NDA017892
TriazolamTRIAZOLAMAphena Pharma Solutions - Tennessee, LLC97164a9c-4bc7-4f15-829e-5f9e653c7fa52017-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 017892
application number: NDA017892
ndc (product): 43353-451

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198318triazolam 0.25 MG Oral TabletPSN97164a9c-4bc7-4f15-829e-5f9e653c7fa51
198318triazolam 0.25 MG Oral TabletSCD97164a9c-4bc7-4f15-829e-5f9e653c7fa51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-451-304335304513030 TABLET in 1 BOTTLE (43353-451-30) 30 tablet1982-11-150000-00-00NoNoCurrent
43353-451-534335304515360 TABLET in 1 BOTTLE (43353-451-53) 60 tablet1982-11-150000-00-00NoNoCurrent