Home NDC 0054-4859 Triazolam
Product NDC 0054-4859
11-digit product format 000544859
Labeler code 0054
Product ID 0054-4859_2efca7ec-b0da-4a4b-9701-91c1ec0c777a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triazolam
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA074224
Marketing category ANDA
Marketing start 2018-10-29
Marketing end 0000-00-00
Substance TRIAZOLAM
Active strength 0 mg/1
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074224-001 TRIAZOLAM TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 A074224-002 TRIAZOLAM TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01
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 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL 1994-06-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL 1994-06-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL AB 1994-06-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL AB 1994-06-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL AB 1994-06-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL AB 1994-06-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL AB 1994-06-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL AB 1994-06-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL AB 1994-06-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL AB 1994-06-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074224-001 TRIAZOLAM 0.125MG TABLET / ORAL AB 1994-06-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074224-002 TRIAZOLAM 0.25MG TABLET / ORAL AB 1994-06-01 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRIAZOLAM ACTIVE INGREDIENT 1HM943223R TRIAZOLAM TABLET [ROXANE LABORATORIES, INC.] 13 TRIAZOLAM ACTIVE MOIETY 1HM943223R TRIAZOLAM TABLET [ROXANE LABORATORIES, INC.] 13 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TRIAZOLAM TABLET [ROXANE LABORATORIES, INC.] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIAZOLAM TABLET [ROXANE LABORATORIES, INC.] 13 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 TRIAZOLAM TABLET [ROXANE LABORATORIES, INC.] 13 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIAZOLAM TABLET [ROXANE LABORATORIES, INC.] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIAZOLAM TABLET [ROXANE LABORATORIES, INC.] 13 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRIAZOLAM TABLET [ROXANE LABORATORIES, INC.] 13 TRIAZOLAM ACTIVE INGREDIENT 1HM943223R TRIAZOLAM TABLET [BRYANT RANCH PREPACK] 3 TRIAZOLAM ACTIVE MOIETY 1HM943223R TRIAZOLAM TABLET [BRYANT RANCH PREPACK] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TRIAZOLAM TABLET [BRYANT RANCH PREPACK] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIAZOLAM TABLET [BRYANT RANCH PREPACK] 3 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 TRIAZOLAM TABLET [BRYANT RANCH PREPACK] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIAZOLAM TABLET [BRYANT RANCH PREPACK] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIAZOLAM TABLET [BRYANT RANCH PREPACK] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRIAZOLAM TABLET [BRYANT RANCH PREPACK] 3 TRIAZOLAM ACTIVE INGREDIENT 1HM943223R TRIAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 2 TRIAZOLAM ACTIVE MOIETY 1HM943223R TRIAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TRIAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 2 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 TRIAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRIAZOLAM TABLET [REBEL DISTRIBUTORS CORP] 2 TRIAZOLAM ACTIVE INGREDIENT 1HM943223R TRIAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 TRIAZOLAM ACTIVE MOIETY 1HM943223R TRIAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TRIAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 TRIAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRIAZOLAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-4859-25 00054485925 100 TABLET in 1 BOTTLE (0054-4859-25) 100 tablet 2018-10-29 0000-00-00 No No Current 0054-4859-29 00054485929 500 TABLET in 1 BOTTLE (0054-4859-29) 500 tablet 2018-10-29 0000-00-00 No No Current