Alprazolam

Product NDC: 72789-024
11-digit product format: 727890024
Labeler code: 72789
Product ID: 72789-024_d9431219-9a19-5fc2-e053-2995a90a0145
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA207507
Marketing category: ANDA
Marketing start: 2018-07-09
Marketing end: 0000-00-00
Substance: ALPRAZOLAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	72789-024		D	Discontinued by firm	2026-10-05
excluded package	package	72789-024	72789-024-06	D	Discontinued by firm	2026-10-05
excluded package	package	72789-024	72789-024-30	D	Discontinued by firm	2026-10-05
excluded package	package	72789-024	72789-024-60	D	Discontinued by firm	2026-10-05
excluded package	package	72789-024	72789-024-90	D	Discontinued by firm	2026-10-05

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 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	72789-024-30
excluded package	package	72789-024-90
excluded package	package	72789-024-06
excluded package	package	72789-024-60

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A207507-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	2018-07-09
A207507-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	2018-07-09
A207507-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	2018-07-09
A207507-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	2018-07-09

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 5 · 172 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
2026-09-14 22:38:34	2026-08	A207507-001	ALPRAZOLAM	0.25MG	TABLET / ORAL		2018-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207507-002	ALPRAZOLAM	0.5MG	TABLET / ORAL		2018-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207507-003	ALPRAZOLAM	1MG	TABLET / ORAL		2018-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207507-004	ALPRAZOLAM	2MG	TABLET / ORAL		2018-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207507-001	ALPRAZOLAM	0.25MG	TABLET / ORAL		2018-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207507-002	ALPRAZOLAM	0.5MG	TABLET / ORAL		2018-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207507-003	ALPRAZOLAM	1MG	TABLET / ORAL		2018-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207507-004	ALPRAZOLAM	2MG	TABLET / ORAL		2018-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207507-001	ALPRAZOLAM	0.25MG	TABLET / ORAL		2018-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207507-002	ALPRAZOLAM	0.5MG	TABLET / ORAL		2018-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207507-003	ALPRAZOLAM	1MG	TABLET / ORAL		2018-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207507-004	ALPRAZOLAM	2MG	TABLET / ORAL		2018-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207507-001	ALPRAZOLAM	0.25MG	TABLET / ORAL		2018-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207507-002	ALPRAZOLAM	0.5MG	TABLET / ORAL		2018-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207507-003	ALPRAZOLAM	1MG	TABLET / ORAL		2018-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207507-004	ALPRAZOLAM	2MG	TABLET / ORAL		2018-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207507-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2018-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207507-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2018-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207507-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2018-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207507-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2018-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207507-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2018-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207507-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2018-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207507-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2018-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207507-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2018-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207507-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2018-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207507-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2018-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207507-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2018-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207507-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2018-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207507-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2018-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207507-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2018-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207507-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2018-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207507-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2018-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207507-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2018-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207507-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2018-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207507-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2018-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207507-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2018-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207507-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	2018-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207507-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	2018-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207507-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	2018-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207507-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	2018-07-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A207507-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207507-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207507-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207507-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207507-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207507-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207507-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207507-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207507-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207507-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207507-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207507-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207507-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207507-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207507-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207507-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207507-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207507-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207507-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207507-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207507-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207507-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207507-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207507-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207507-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207507-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207507-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207507-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207507-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207507-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207507-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207507-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207507-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207507-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207507-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207507-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207507-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207507-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207507-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207507-004	AB	1	`9b2671bbb829…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ffbe5ef-58ff-88b9-e291-045e0f861f4f	Product name	4	20180827
1f9e6d58-49d3-d9c1-e570-4bb0466a2c0b	Product name	1	20140508
a1a11520-f3e2-68fa-8bd9-e80b271ef797	Product name	1	20140508
d153678e-a3c8-bad8-cfe0-385656dde0e7	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-024-06	EA - Each	72789-024	21209447-71ed-4090-8cb0-6fcd6b2128dd	1	2020-04-20
72789-024-30	EA - Each	72789-024	5d52db10-2287-4781-9ac7-f30c3cd08c4a	1	2020-04-20
72789-024-60	EA - Each	72789-024	38ecee49-7434-4bd3-8e2c-d5a49f472286	1	2020-05-08
72789-024-90	EA - Each	72789-024	b3b64f47-caf8-4e32-8f72-7c860e83bdaf	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-024	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	12	Legacy NDC	20241010_30f8a7db-be72-4b3d-bd0a-269306285100.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YU55MQ3IZY	ALPRAZOLAM	28981-97-7	ALPRAZOLAM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-024-06	72789002406	6 TABLET in 1 BOTTLE, PLASTIC (72789-024-06)	6 tablet	2020-02-19	0000-00-00	No	No	Current
72789-024-30	72789002430	30 TABLET in 1 BOTTLE, PLASTIC (72789-024-30)	30 tablet	2020-02-24	0000-00-00	No	No	Current
72789-024-60	72789002460	60 TABLET in 1 BOTTLE, PLASTIC (72789-024-60)	60 tablet	2020-03-10	0000-00-00	No	No	Current
72789-024-90	72789002490	90 TABLET in 1 BOTTLE, PLASTIC (72789-024-90)	90 tablet	2019-10-31	0000-00-00	No	No	Current