Alprazolam

Product NDC
67544-006
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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67544-006DDiscontinued by firm2026-10-12
excluded packagepackage67544-00667544-006-15DDiscontinued by firm2026-10-12
excluded packagepackage67544-00667544-006-20DDiscontinued by firm2026-10-12
excluded packagepackage67544-00667544-006-30DDiscontinued by firm2026-10-12
excluded packagepackage67544-00667544-006-45DDiscontinued by firm2026-10-12
excluded packagepackage67544-00667544-006-53DDiscontinued by firm2026-10-12
excluded packagepackage67544-00667544-006-60DDiscontinued by firm2026-10-12
excluded packagepackage67544-00667544-006-70DDiscontinued by firm2026-10-12
excluded packagepackage67544-00667544-006-75DDiscontinued by firm2026-10-12
excluded packagepackage67544-00667544-006-80DDiscontinued 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 2 · 120 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 packagepackage67544-006-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-006-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-006-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-006-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-006-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-006-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-006-75d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-006-70d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-006-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-006-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-006-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-006-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-006-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-006-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-006-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-006-75f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-006-70f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-006-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-006-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-006-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-006-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-006-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-006-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-006-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-006-752ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-006-702ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-006-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-006-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-006-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-006-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-006-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-006-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-006-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-006-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-006-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-006-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-006-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-006-53cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-006-80cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-006-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-006-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-006-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-006-75cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-006-70cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-006-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-006-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-006-53cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-006-80cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-006-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-006-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-006-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-006-75cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-006-70cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-006-60cdf11ea48f46…ba0047e9e063…

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
67544-006-15EA - Each67544-006677988d3-6ada-4c4f-bc99-46cb17131c7212019-04-11
67544-006-20EA - Each67544-00672907f2e-396b-4176-9b29-0969b5f83ec812019-04-11
67544-006-30EA - Each67544-006b9e8d73d-f0cc-421e-8ee4-da373066764d12019-04-11
67544-006-45EA - Each67544-006dd2d8792-a699-4a46-8311-d5917f7178df12019-04-11
67544-006-53EA - Each67544-0061b2c8d58-7f8a-4fa2-ad5f-a3701d9bee3112019-04-11
67544-006-70EA - Each67544-0063db1a2ff-26fe-409a-bfad-d6d624ab9d4a12019-04-11
67544-006-75EA - Each67544-00634eb6759-d835-4001-8020-3a496678c44a12019-04-11
67544-006-80EA - Each67544-006cd710613-150e-4002-b63c-ff3714b9a9a612019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-006-156754400061515 TABLET in 1 BOTTLE, PLASTIC (67544-006-15) 15 tablet2017-07-280000-00-00NoNoCurrent
67544-006-206754400062020 TABLET in 1 BOTTLE, PLASTIC (67544-006-20) 20 tablet2017-08-030000-00-00NoNoCurrent
67544-006-306754400063030 TABLET in 1 BOTTLE, PLASTIC (67544-006-30) 30 tablet2016-04-050000-00-00NoNoCurrent
67544-006-456754400064545 TABLET in 1 BOTTLE, PLASTIC (67544-006-45) 45 tablet2017-08-040000-00-00NoNoCurrent
67544-006-536754400065360 TABLET in 1 BOTTLE, PLASTIC (67544-006-53) 60 tablet2016-04-050000-00-00NoNoCurrent
67544-006-606754400066090 TABLET in 1 BOTTLE, PLASTIC (67544-006-60) 90 tablet2016-04-050000-00-00NoNoCurrent
67544-006-7067544000670120 TABLET in 1 BOTTLE, PLASTIC (67544-006-70) 120 tablet2016-04-050000-00-00NoNoCurrent
67544-006-7567544000675150 TABLET in 1 BOTTLE, PLASTIC (67544-006-75) 150 tablet2017-07-290000-00-00NoNoCurrent
67544-006-8067544000680180 TABLET in 1 BOTTLE, PLASTIC (67544-006-80) 180 tablet2017-07-290000-00-00NoNoCurrent