Alprazolam

Product NDC: 0228-2031
11-digit product format: 002282031
Labeler code: 0228
Product ID: 0228-2031_9cf12473-8eb9-4248-bfce-76eef6b82bfd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA074342
Marketing category: ANDA
Marketing start: 1993-10-01
Substance: ALPRAZOLAM
Active strength: 1 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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	0228-2031		UNFINISHED	Active or certified unfinished drug listing	2026-08-03
unfinished package	package	0228-2031	0228-2031-00	UNFINISHED	Active or certified unfinished drug listing	2026-08-03
unfinished package	package	0228-2031	0228-2031-77	UNFINISHED	Active or certified unfinished drug listing	2026-08-03

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 · 56 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0228-2031-77	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0228-2031-00	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0228-2031-77	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0228-2031-00	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0228-2031-77	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0228-2031-00	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0228-2031-77	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0228-2031-00	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0228-2031-77	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0228-2031-00	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0228-2031-77	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0228-2031-00	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0228-2031-77	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0228-2031-00	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0228-2031-77	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0228-2031-00	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0228-2031-77	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0228-2031-00	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0228-2031-77	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0228-2031-00	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0228-2031-77	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0228-2031-00	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0228-2031-77	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0228-2031-00	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0228-2031-77	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0228-2031-00	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0228-2031-77	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0228-2031-00	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	0228-2031-00	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	0228-2031-00	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	0228-2031-00	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	0228-2031-00	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	0228-2031-00	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	0228-2031-00	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	0228-2031-00	`5b2001dcd8f5…`	`54b53d4dc9e4…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A074342-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31
A074342-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31
A074342-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31
A074342-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A074342-001	AB
A074342-002	AB
A074342-003	AB
A074342-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074342-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-003	ALPRAZOLAM	1MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-004	ALPRAZOLAM	2MG	TABLET / ORAL	AB	1993-10-31	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074342-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074342-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074342-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074342-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074342-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074342-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074342-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074342-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074342-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074342-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074342-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074342-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074342-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALPRAZOLAM	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YU55MQ3IZY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197321	Internal RxNorm lookup
197322	Internal RxNorm lookup
308047	Internal RxNorm lookup
308048	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
a23063c0-099a-4256-b95f-3a857bbf704b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
2ffbe5ef-58ff-88b9-e291-045e0f861f4f	Product name	4	20180827
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0228-2031-10	Alprazolam	100 in 1 BOTTLE	TABLET	100	22
0228-2031-50	Alprazolam	500 in 1 BOTTLE	TABLET	500	22
0228-2031-96	Alprazolam	1000 in 1 BOTTLE	TABLET	1000	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-2031-10	EA - Each	0228-2031	83e30e41-6cac-437f-9d4f-4ed20dc801dd	1	2012-07-24
0228-2031-50	EA - Each	0228-2031	6efe7ab8-828d-43e6-8979-9efc342aa924	1	2012-07-24
0228-2031-96	EA - Each	0228-2031	f1fdba81-8ffc-42d2-9953-48e5fc05606c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [MAJOR PHARMACEUTICALS]	13
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	8
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [APOTHECA, INC]	2
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [APOTHECA, INC]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [APOTHECA, INC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [APOTHECA, INC]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ALPRAZOLAM TABLET [APOTHECA, INC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALPRAZOLAM TABLET [APOTHECA, INC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [APOTHECA, INC]	2
ALPRAZOLAM	ACTIVE INGREDIENT	YU55MQ3IZY	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
ALPRAZOLAM	ACTIVE MOIETY	YU55MQ3IZY	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALPRAZOLAM TABLET [BLENHEIM PHARMACAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0228-2031	ALPRAZOLAM TABLET [ACTAVIS PHARMA, INC.]	21	Current NDC, Legacy NDC, 3 package rows	20250116_a23063c0-099a-4256-b95f-3a857bbf704b.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alprazolam	ALPRAZOLAM	A-S Medication Solutions	8ef75d22-4a7c-48d5-a532-5a43b8593e7c	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	5040e1ed-32d6-4757-a0ee-b8240f3e7cf5	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	PD-Rx Pharmaceuticals, Inc.	2f16ff78-1262-4bb8-9a25-822c13c4746f	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	b39e2bc8-b68f-0f4e-e053-2995a90a00fd	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Advanced Rx of Tennessee, LLC	b4cd647f-1ba3-334e-e053-2995a90af352	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Quality Care Products, LLC	8be0bc5e-3566-4fbd-a27d-634e64fd6d78	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	aaf7979c-168a-0da2-e053-2995a90a4d12	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	NuCare Pharmaceuticals,Inc.	b43df4ca-8d28-7b3a-e053-2a95a90aa4d7	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	8ca8e0fc-6c3d-48d4-ad04-708182b45350	2024-05-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Bryant Ranch Prepack	25781f50-d309-4c4f-9e21-c019e068d101	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Actavis Pharma, Inc.	a23063c0-099a-4256-b95f-3a857bbf704b	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342 ndc (product): 0228-2031
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	29ddd9f2-c116-467b-8db3-38166482aea0	2018-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342
Alprazolam	ALPRAZOLAM	Aphena Pharma Solutions - Tennessee, LLC	2717699a-c8b6-4590-937a-cb86eadc5296	2018-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074342 application number: ANDA074342

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	a23063c0-099a-4256-b95f-3a857bbf704b	22
308048	ALPRAZolam 0.5 MG Oral Tablet	PSN	a23063c0-099a-4256-b95f-3a857bbf704b	22
197321	ALPRAZolam 1 MG Oral Tablet	PSN	a23063c0-099a-4256-b95f-3a857bbf704b	22
197322	ALPRAZolam 2 MG Oral Tablet	PSN	a23063c0-099a-4256-b95f-3a857bbf704b	22
308047	alprazolam 0.25 MG Oral Tablet	SCD	a23063c0-099a-4256-b95f-3a857bbf704b	22
308048	alprazolam 0.5 MG Oral Tablet	SCD	a23063c0-099a-4256-b95f-3a857bbf704b	22
197321	alprazolam 1 MG Oral Tablet	SCD	a23063c0-099a-4256-b95f-3a857bbf704b	22
197322	alprazolam 2 MG Oral Tablet	SCD	a23063c0-099a-4256-b95f-3a857bbf704b	22
197321	ALPRAZolam 1 MG Oral Tablet	PSN	2f16ff78-1262-4bb8-9a25-822c13c4746f	20
197321	alprazolam 1 MG Oral Tablet	SCD	2f16ff78-1262-4bb8-9a25-822c13c4746f	20
197321	ALPRAZolam 1 MG Oral Tablet	PSN	b4cd647f-1ba3-334e-e053-2995a90af352	6
197321	alprazolam 1 MG Oral Tablet	SCD	b4cd647f-1ba3-334e-e053-2995a90af352	6
197321	ALPRAZolam 1 MG Oral Tablet	PSN	8be0bc5e-3566-4fbd-a27d-634e64fd6d78	4
197321	alprazolam 1 MG Oral Tablet	SCD	8be0bc5e-3566-4fbd-a27d-634e64fd6d78	4
197321	ALPRAZolam 1 MG Oral Tablet	PSN	176bcb54-bc3c-423b-b636-c4d1bf156b65	2
197321	alprazolam 1 MG Oral Tablet	SCD	176bcb54-bc3c-423b-b636-c4d1bf156b65	2
308047	ALPRAZolam 0.25 MG Oral Tablet	PSN	0e6cb388-f5f4-40c7-add2-0d5375553805	1
197321	ALPRAZolam 1 MG Oral Tablet	PSN	29ddd9f2-c116-467b-8db3-38166482aea0	1
197321	ALPRAZolam 1 MG Oral Tablet	PSN	0e6cb388-f5f4-40c7-add2-0d5375553805	1
197322	ALPRAZolam 2 MG Oral Tablet	PSN	0e6cb388-f5f4-40c7-add2-0d5375553805	1
308047	alprazolam 0.25 MG Oral Tablet	SCD	0e6cb388-f5f4-40c7-add2-0d5375553805	1
197321	alprazolam 1 MG Oral Tablet	SCD	29ddd9f2-c116-467b-8db3-38166482aea0	1
197321	alprazolam 1 MG Oral Tablet	SCD	0e6cb388-f5f4-40c7-add2-0d5375553805	1
197322	alprazolam 2 MG Oral Tablet	SCD	0e6cb388-f5f4-40c7-add2-0d5375553805	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0228-2031-00	00228203100	77000 TABLET in 1 BAG (0228-2031-00)	77000 tablet	30-JUL-15				Current
0228-2031-10	00228203110	100 TABLET in 1 BOTTLE (0228-2031-10)	100 tablet	1993-10-01	0000-00-00	No	No	Current
0228-2031-50	00228203150	500 TABLET in 1 BOTTLE (0228-2031-50)	500 tablet	1993-10-01	0000-00-00	No	No	Current
0228-2031-77	00228203177	92304 TABLET in 1 CONTAINER (0228-2031-77)	92304 tablet	17-JAN-24				Current
0228-2031-96	00228203196	1000 TABLET in 1 BOTTLE (0228-2031-96)	1000 tablet	1993-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alprazolam	PD-Rx Pharmaceuticals, Inc.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	20
Alprazolam Tablet	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Alprazolam	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	4
Alprazolam	REMEDYREPACK INC.	2024-03-14	HUMAN PRESCRIPTION DRUG LABEL	3
Alprazolam	Actavis Pharma, Inc.	2023-01-02	HUMAN PRESCRIPTION DRUG LABEL	21
Alprazolam Tablets, USP	Major Pharmaceuticals	2019-11-18	HUMAN PRESCRIPTION DRUG LABEL	20
Alprazolam Tablets, USP	Bryant Ranch Prepack	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	8
Alprazolam Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2018-08-23	HUMAN PRESCRIPTION DRUG LABEL	1
Alprazolam Tablets, USP	NCS HealthCare of KY, Inc dba Vangard Labs	2016-01-18	HUMAN PRESCRIPTION DRUG LABEL	2
ALPRAZOLAM TABLETS, USP CIV	APOTHECA, INC	2014-10-31	HUMAN PRESCRIPTION DRUG LABEL	2
Alprazolam Tablets, USP	Blenheim Pharmacal, Inc.	2013-05-28	HUMAN PRESCRIPTION DRUG LABEL	1