Triazolam

Product NDC: 50742-645
11-digit product format: 507420645
Labeler code: 50742
Product ID: 50742-645_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: .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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214219-001	TRIAZOLAM	TRIAZOLAM	0.125MG	TABLET / ORAL	AB		2020-10-20
A214219-002	TRIAZOLAM	TRIAZOLAM	0.25MG	TABLET / ORAL	AB		2020-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214219-001	AB
A214219-002	AB

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 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214219-001	TRIAZOLAM	0.125MG	TABLET / ORAL	AB	2020-10-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214219-002	TRIAZOLAM	0.25MG	TABLET / ORAL	AB	2020-10-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214219-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214219-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214219-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214219-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214219-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214219-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214219-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214219-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214219-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214219-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214219-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214219-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214219-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214219-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214219-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214219-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214219-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214219-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214219-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214219-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214219-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214219-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214219-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214219-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214219-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214219-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214219-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214219-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214219-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214219-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214219-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214219-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214219-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214219-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214219-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214219-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214219-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214219-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214219-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214219-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIAZOLAM	.125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1HM943223R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198317	Internal RxNorm lookup
198318	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a0c99f0b-4122-4611-9b53-80fadfceacb6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
50ba0308-e38d-ba7a-26f9-ab61326900c2	Product name	4	20240208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50742-645-01	Triazolam	100 in 1 BOTTLE, PLASTIC	TABLET	100		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-645	TRIAZOLAM TABLET [INGENUS PHARMACEUTICALS, LLC]	7	Current NDC, Legacy NDC, 1 package rows	20230627_a0c99f0b-4122-4611-9b53-80fadfceacb6.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triazolam	TRIAZOLAM	Proficient Rx LP	ba1d8955-41f8-4b4d-8ed8-e92667e294a1	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214219 application number: ANDA214219
Triazolam	TRIAZOLAM	PD-Rx Pharmaceuticals, Inc.	f8ca4773-e201-4cb9-8869-5ee07ba1d0bf	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214219 application number: ANDA214219
Triazolam	TRIAZOLAM	Bryant Ranch Prepack	5fccc31d-32c9-49e7-91a9-664cc726872b	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214219 application number: ANDA214219
Triazolam	TRIAZOLAM	A-S Medication Solutions	5a330f08-5d8f-4f8d-8847-a45b734412b4	2023-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214219 application number: ANDA214219
Triazolam	TRIAZOLAM	Ingenus Pharmaceuticals, LLC	a0c99f0b-4122-4611-9b53-80fadfceacb6	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214219 application number: ANDA214219 ndc (product): 50742-645

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1HM943223R	TRIAZOLAM	28911-01-5	TRIAZOLAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198317	triazolam 0.125 MG Oral Tablet	PSN	a0c99f0b-4122-4611-9b53-80fadfceacb6	7
198318	triazolam 0.25 MG Oral Tablet	PSN	a0c99f0b-4122-4611-9b53-80fadfceacb6	7
198317	triazolam 0.125 MG Oral Tablet	SCD	a0c99f0b-4122-4611-9b53-80fadfceacb6	7
198318	triazolam 0.25 MG Oral Tablet	SCD	a0c99f0b-4122-4611-9b53-80fadfceacb6	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-645-01	50742064501	100 TABLET in 1 BOTTLE, PLASTIC (50742-645-01)	100 tablet	2020-10-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Triazolam	Ingenus Pharmaceuticals, LLC \| Novast Laboratories Ltd. \| Ingenus Pharmaceuticals NJ, LLC	2023-01-01	HUMAN PRESCRIPTION DRUG LABEL	7