Alprazolam

Product NDC
68788-7596
11-digit product format
687887596
Labeler code
68788
Product ID
68788-7596_c2ee3758-177c-4254-9831-260f67bc6f93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA207507
Marketing category
ANDA
Marketing start
2020-02-13
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7596DDiscontinued by firm2026-08-07
excluded packagepackage68788-759668788-7596-2DDiscontinued by firm2026-08-07
excluded packagepackage68788-759668788-7596-3DDiscontinued by firm2026-08-07
excluded packagepackage68788-759668788-7596-6DDiscontinued by firm2026-08-07
excluded packagepackage68788-759668788-7596-8DDiscontinued by firm2026-08-07
excluded packagepackage68788-759668788-7596-9DDiscontinued by firm2026-08-07

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7596-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7596-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7596-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7596-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7596-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7596-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7596-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7596-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7596-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7596-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7596-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7596-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7596-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7596-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7596-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7596-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7596-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7596-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7596-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7596-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7596-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7596-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7596-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7596-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7596-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7596-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7596-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7596-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7596-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7596-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-7596-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-7596-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-7596-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-7596-8302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-7596-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-7596-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-7596-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-7596-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-7596-8ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-7596-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-7596-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-7596-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-7596-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-7596-80efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-7596-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-7596-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-7596-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-7596-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-7596-8ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-7596-9ad56d346431e…cc804d4bbf1e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207507-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORAL2018-07-09
A207507-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORAL2018-07-09
A207507-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORAL2018-07-09
A207507-004ALPRAZOLAMALPRAZOLAM2MGTABLET / ORAL2018-07-09

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207507-001ALPRAZOLAM0.25MGTABLET / ORAL2018-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207507-002ALPRAZOLAM0.5MGTABLET / ORAL2018-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207507-003ALPRAZOLAM1MGTABLET / ORAL2018-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207507-004ALPRAZOLAM2MGTABLET / ORAL2018-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-001ALPRAZOLAM0.25MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-002ALPRAZOLAM0.5MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-003ALPRAZOLAM1MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-004ALPRAZOLAM2MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-09d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A207507-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207507-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207507-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207507-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207507-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207507-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207507-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207507-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207507-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207507-004AB1301d65b070ca…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7596-2EA - Each68788-7596de44add8-2f20-4a68-9f9d-c8259f0d6d7112020-04-20
68788-7596-3EA - Each68788-7596d8bd13bb-0fcb-4542-b9ee-94af55e18be612020-04-20
68788-7596-6EA - Each68788-7596fb7515ad-99c3-4fee-b195-30f937d6f98712020-04-20
68788-7596-8EA - Each68788-7596369cb590-76f9-4245-801e-a29e6507801212020-04-20
68788-7596-9EA - Each68788-759658f6c159-497f-43cb-af96-bad40ee6249012020-04-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7596-26878875960220 TABLET in 1 BOTTLE (68788-7596-2) 20 tablet2020-02-130000-00-00NoNoCurrent
68788-7596-36878875960330 TABLET in 1 BOTTLE (68788-7596-3) 30 tablet2020-02-130000-00-00NoNoCurrent
68788-7596-66878875960660 TABLET in 1 BOTTLE (68788-7596-6) 60 tablet2020-02-130000-00-00NoNoCurrent
68788-7596-868788759608120 TABLET in 1 BOTTLE (68788-7596-8) 120 tablet2020-02-130000-00-00NoNoCurrent
68788-7596-96878875960990 TABLET in 1 BOTTLE (68788-7596-9) 90 tablet2020-02-130000-00-00NoNoCurrent