Alprazolam

Product NDC: 71205-227
11-digit product format: 712050227
Labeler code: 71205
Product ID: 71205-227_c256eb0e-ff92-498d-9a9d-820b63126233
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
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	71205-227		D	Discontinued by firm	2026-10-16
excluded package	package	71205-227	71205-227-10	D	Discontinued by firm	2026-10-16
excluded package	package	71205-227	71205-227-30	D	Discontinued by firm	2026-10-16
excluded package	package	71205-227	71205-227-60	D	Discontinued by firm	2026-10-16
excluded package	package	71205-227	71205-227-90	D	Discontinued by firm	2026-10-16

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-227-10	EA - Each	71205-227	2ea6de7f-76bb-482f-bedf-773e3dfa0edf	1	2022-12-07
71205-227-30	EA - Each	71205-227	4d857202-e823-4be1-8c6b-e762febfc8a1	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-227	ALPRAZOLAM TABLET [PROFICIENT RX LP]	6	Legacy NDC	20221116_2d04c305-70d6-4a99-8c82-720c5398a46c.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
71205-227-10	71205022710	10 TABLET in 1 BOTTLE (71205-227-10)	10 tablet	2022-11-10	0000-00-00	No	No	Current
71205-227-30	71205022730	30 TABLET in 1 BOTTLE (71205-227-30)	30 tablet	2019-02-01	0000-00-00	No	No	Current
71205-227-60	71205022760	60 TABLET in 1 BOTTLE (71205-227-60)	60 tablet	2019-02-01	0000-00-00	No	No	Current
71205-227-90	71205022790	90 TABLET in 1 BOTTLE (71205-227-90)	90 tablet	2019-02-01	0000-00-00	No	No	Current