Alprazolam

Product NDC: 72789-042
11-digit product format: 727890042
Labeler code: 72789
Product ID: 72789-042_db0c30b3-706f-41df-e053-2a95a90a31be
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: 0 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72789-042		D	Discontinued by firm		2026-10-15
excluded package	package	72789-042	72789-042-30	D	Discontinued by firm		2026-10-15

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	72789-042		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72789-042	72789-042-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A207507-001	ALPRAZOLAM	0.25MG	TABLET / ORAL		2018-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207507-002	ALPRAZOLAM	0.5MG	TABLET / ORAL		2018-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207507-003	ALPRAZOLAM	1MG	TABLET / ORAL		2018-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207507-004	ALPRAZOLAM	2MG	TABLET / ORAL		2018-07-09	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207507-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207507-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207507-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207507-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207507-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207507-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207507-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207507-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207507-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207507-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207507-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207507-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207507-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207507-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207507-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207507-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207507-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207507-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207507-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207507-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207507-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207507-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207507-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207507-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207507-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A207507-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A207507-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A207507-004	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207507-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207507-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207507-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207507-004	AB	1	`cb3db0bc1861…`

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
72789-042-30	EA - Each	72789-042	06f7835a-0c4b-400c-8e6f-8fe2b24b02be	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-042	ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.]	11	Legacy NDC	20241010_ee8261fd-ea38-47ef-b980-b79629e4a3db.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
72789-042-30	72789004230	30 TABLET in 1 BOTTLE, PLASTIC (72789-042-30)	30 tablet	2019-12-26	0000-00-00	No	No	Current