Triazolam

Product NDC
70710-1521
11-digit product format
707101521
Labeler code
70710
Product ID
70710-1521_4c2fb12f-623b-4dc9-a9e0-7fac953f5cf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triazolam
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA213003
Marketing category
ANDA
Marketing start
2022-12-30
Substance
TRIAZOLAM
Active strength
.125 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213003-001TRIAZOLAMTRIAZOLAM0.125MGTABLET / ORALAB2022-12-28
A213003-002TRIAZOLAMTRIAZOLAM0.25MGTABLET / ORALAB2022-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213003-001AB
A213003-002AB

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 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-288072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-286a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-281c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-28ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-28a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213003-001TRIAZOLAM0.125MGTABLET / ORALAB2022-12-289b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213003-002TRIAZOLAM0.25MGTABLET / ORALAB2022-12-289b2671bbb829…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213003-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213003-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213003-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213003-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213003-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213003-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213003-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213003-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213003-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213003-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213003-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213003-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213003-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213003-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213003-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213003-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213003-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213003-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213003-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213003-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213003-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213003-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213003-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213003-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213003-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213003-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213003-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213003-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213003-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213003-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213003-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213003-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213003-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213003-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213003-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213003-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213003-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213003-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213003-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213003-002AB19b2671bbb829…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAZOLAM.125 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198317Internal RxNorm lookup
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
8d414eb8-eec9-486f-90fc-00eed0cf7dafAvailable 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
70710-1521-1Triazolam100 in 1 BOTTLETABLET1002
70710-1521-5Triazolam500 in 1 BOTTLETABLET5002
70710-1521-8Triazolam10 in 1 BOTTLETABLET102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1521-1EA - Each70710-1521f1550fb3-23ed-470a-98a8-cd00bca751fb12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1521TRIAZOLAM TABLET [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 3 package rows20230222_8d414eb8-eec9-486f-90fc-00eed0cf7daf.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TriazolamTRIAZOLAMA-S Medication Solutions0a96c618-1869-4cb6-b9f3-549e8581af722025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213003
application number: ANDA213003
TriazolamTRIAZOLAMZydus Lifesciences Limited4084da13-5825-4399-ad69-de701508c71d2024-08-14Exact identifier
application applno (ANDA): 213003
application number: ANDA213003
TriazolamTRIAZOLAMZydus Pharmaceuticals USA Inc.8d414eb8-eec9-486f-90fc-00eed0cf7daf2023-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213003
application number: ANDA213003
ndc (product): 70710-1521

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198317triazolam 0.125 MG Oral TabletPSN8d414eb8-eec9-486f-90fc-00eed0cf7daf2
198318triazolam 0.25 MG Oral TabletPSN8d414eb8-eec9-486f-90fc-00eed0cf7daf2
198317triazolam 0.125 MG Oral TabletSCD8d414eb8-eec9-486f-90fc-00eed0cf7daf2
198318triazolam 0.25 MG Oral TabletSCD8d414eb8-eec9-486f-90fc-00eed0cf7daf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1521-170710152101100 TABLET in 1 BOTTLE (70710-1521-1) 100 tablet2022-12-300000-00-00NoNoCurrent
70710-1521-570710152105500 TABLET in 1 BOTTLE (70710-1521-5) 500 tablet2022-12-300000-00-00NoNoCurrent
70710-1521-87071015210810 TABLET in 1 BOTTLE (70710-1521-8) 10 tablet2022-12-300000-00-00NoNoCurrent