Alprazolam

Product NDC: 67544-006
Requested package NDC: 67544-006-45
11-digit product format: 675440006
Labeler code: 67544
Product ID: 67544-006_8e0b1f7c-43cc-4e9f-9b18-6d972e94a97b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alprazolam
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA074215
Marketing category: ANDA
Marketing start: 2012-07-23
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67544-006	67544-006-45	D	Discontinued by firm		2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A074215-001	ALPRAZOLAM	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27
A074215-002	ALPRAZOLAM	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27
A074215-003	ALPRAZOLAM	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27
A074215-004	ALPRAZOLAM	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074215-001	ALPRAZOLAM	0.25MG	TABLET / ORAL	1994-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074215-002	ALPRAZOLAM	0.5MG	TABLET / ORAL	1994-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074215-003	ALPRAZOLAM	1MG	TABLET / ORAL	1994-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074215-004	ALPRAZOLAM	2MG	TABLET / ORAL	1994-01-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074215-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074215-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074215-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074215-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074215-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074215-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074215-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074215-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074215-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074215-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074215-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A074215-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074215-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074215-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074215-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A074215-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074215-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074215-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074215-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A074215-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074215-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074215-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074215-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074215-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074215-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074215-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074215-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074215-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074215-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074215-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074215-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074215-004	AB	1	`ea99ee380514…`

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
67544-006-15	EA - Each	67544-006	677988d3-6ada-4c4f-bc99-46cb17131c72	1	2019-04-11
67544-006-20	EA - Each	67544-006	72907f2e-396b-4176-9b29-0969b5f83ec8	1	2019-04-11
67544-006-30	EA - Each	67544-006	b9e8d73d-f0cc-421e-8ee4-da373066764d	1	2019-04-11
67544-006-45	EA - Each	67544-006	dd2d8792-a699-4a46-8311-d5917f7178df	1	2019-04-11
67544-006-53	EA - Each	67544-006	1b2c8d58-7f8a-4fa2-ad5f-a3701d9bee31	1	2019-04-11
67544-006-70	EA - Each	67544-006	3db1a2ff-26fe-409a-bfad-d6d624ab9d4a	1	2019-04-11
67544-006-75	EA - Each	67544-006	34eb6759-d835-4001-8020-3a496678c44a	1	2019-04-11
67544-006-80	EA - Each	67544-006	cd710613-150e-4002-b63c-ff3714b9a9a6	1	2019-04-11

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
67544-006-45	67544000645	45 TABLET in 1 BOTTLE, PLASTIC (67544-006-45)	45 tablet	2017-08-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alprazolam - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2019-03-21	HUMAN PRESCRIPTION DRUG LABEL	1