Alprazolam

Product NDC
0378-4005
11-digit product format
003784005
Labeler code
0378
Product ID
0378-4005_c0c67127-79af-4c14-8d08-1c41ee7cd3bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074215
Marketing category
ANDA
Marketing start
1994-01-28
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
2021-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-4005DDiscontinued by firm2026-10-12
excluded packagepackage0378-40050378-4005-05DDiscontinued by firm2026-10-12

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 · 24 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 packagepackage0378-4005-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0378-4005-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0378-4005-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0378-4005-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0378-4005-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0378-4005-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0378-4005-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0378-4005-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0378-4005-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0378-4005-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0378-4005-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0378-4005-05557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074215-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORAL1994-01-27
A074215-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORAL1994-01-27
A074215-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORAL1994-01-27
A074215-004ALPRAZOLAMALPRAZOLAM2MGTABLET / ORAL1994-01-27

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074215-001ALPRAZOLAM0.25MGTABLET / ORAL1994-01-2784e616aacf4f…
2026-09-14 22:38:342026-08A074215-002ALPRAZOLAM0.5MGTABLET / ORAL1994-01-2784e616aacf4f…
2026-09-14 22:38:342026-08A074215-003ALPRAZOLAM1MGTABLET / ORAL1994-01-2784e616aacf4f…
2026-09-14 22:38:342026-08A074215-004ALPRAZOLAM2MGTABLET / ORAL1994-01-2784e616aacf4f…
2026-08-18 06:07:402026-07A074215-001ALPRAZOLAM0.25MGTABLET / ORAL1994-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074215-002ALPRAZOLAM0.5MGTABLET / ORAL1994-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074215-003ALPRAZOLAM1MGTABLET / ORAL1994-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074215-004ALPRAZOLAM2MGTABLET / ORAL1994-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074215-001ALPRAZOLAM0.25MGTABLET / ORAL1994-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074215-002ALPRAZOLAM0.5MGTABLET / ORAL1994-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074215-003ALPRAZOLAM1MGTABLET / ORAL1994-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074215-004ALPRAZOLAM2MGTABLET / ORAL1994-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074215-001ALPRAZOLAM0.25MGTABLET / ORAL1994-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074215-002ALPRAZOLAM0.5MGTABLET / ORAL1994-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074215-003ALPRAZOLAM1MGTABLET / ORAL1994-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074215-004ALPRAZOLAM2MGTABLET / ORAL1994-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074215-001ALPRAZOLAM0.25MGTABLET / ORAL1994-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074215-002ALPRAZOLAM0.5MGTABLET / ORAL1994-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074215-003ALPRAZOLAM1MGTABLET / ORAL1994-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074215-004ALPRAZOLAM2MGTABLET / ORAL1994-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074215-001ALPRAZOLAM0.25MGTABLET / ORAL1994-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074215-002ALPRAZOLAM0.5MGTABLET / ORAL1994-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074215-003ALPRAZOLAM1MGTABLET / ORAL1994-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074215-004ALPRAZOLAM2MGTABLET / ORAL1994-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074215-001ALPRAZOLAM0.25MGTABLET / ORAL1994-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074215-002ALPRAZOLAM0.5MGTABLET / ORAL1994-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074215-003ALPRAZOLAM1MGTABLET / ORAL1994-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074215-004ALPRAZOLAM2MGTABLET / ORAL1994-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074215-001ALPRAZOLAM0.25MGTABLET / ORAL1994-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074215-002ALPRAZOLAM0.5MGTABLET / ORAL1994-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074215-003ALPRAZOLAM1MGTABLET / ORAL1994-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074215-004ALPRAZOLAM2MGTABLET / ORAL1994-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074215-001ALPRAZOLAM0.25MGTABLET / ORAL1994-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074215-002ALPRAZOLAM0.5MGTABLET / ORAL1994-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074215-003ALPRAZOLAM1MGTABLET / ORAL1994-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074215-004ALPRAZOLAM2MGTABLET / ORAL1994-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074215-001ALPRAZOLAM0.25MGTABLET / ORAL1994-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074215-002ALPRAZOLAM0.5MGTABLET / ORAL1994-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074215-003ALPRAZOLAM1MGTABLET / ORAL1994-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074215-004ALPRAZOLAM2MGTABLET / ORAL1994-01-275bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A074215-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074215-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074215-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074215-004AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074215-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074215-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074215-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074215-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074215-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A074215-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A074215-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A074215-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074215-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A074215-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A074215-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A074215-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074215-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A074215-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A074215-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A074215-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074215-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A074215-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A074215-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A074215-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074215-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074215-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074215-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074215-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074215-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074215-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074215-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074215-004AB1ea99ee380514…

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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4005-01EA - Each0378-4005db8fb490-db5b-4dae-b0a6-89478ea866c712012-07-24
0378-4005-05EA - Each0378-40050a7e8ac7-49d3-4c5a-8d4e-6573188690a912012-07-24
0378-4005-77EA - Each0378-40057fbd7360-9bc3-444a-a240-e4090991e3c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALPRAZOLAM TABLET [MYLAN INSTITUTIONAL INC.]5
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALPRAZOLAM TABLET [MYLAN PHARMACEUTICALS INC.]4
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [PROFICIENT RX LP]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALPRAZOLAM TABLET [PROFICIENT RX LP]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [PROFICIENT RX LP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALPRAZOLAM TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALPRAZOLAM TABLET [PROFICIENT RX LP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALPRAZOLAM TABLET [PROFICIENT RX LP]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-4005-0500378400505500 TABLET in 1 BOTTLE, PLASTIC (0378-4005-05) 500 tablet1994-01-280000-00-00NoNoCurrent