ALPRAZOLAM

Product NDC
63629-1541
11-digit product format
636291541
Labeler code
63629
Product ID
63629-1541_76f07536-e338-4984-ba2a-148ce9c5a92d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077996
Marketing category
ANDA
Marketing start
2007-03-28
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1541DDiscontinued by firm2026-10-05
excluded packagepackage63629-154163629-1541-0DDiscontinued by firm2026-10-05
excluded packagepackage63629-154163629-1541-1DDiscontinued by firm2026-10-05
excluded packagepackage63629-154163629-1541-2DDiscontinued by firm2026-10-05
excluded packagepackage63629-154163629-1541-3DDiscontinued by firm2026-10-05
excluded packagepackage63629-154163629-1541-4DDiscontinued by firm2026-10-05
excluded packagepackage63629-154163629-1541-5DDiscontinued by firm2026-10-05
excluded packagepackage63629-154163629-1541-6DDiscontinued by firm2026-10-05
excluded packagepackage63629-154163629-1541-7DDiscontinued by firm2026-10-05
excluded packagepackage63629-154163629-1541-8DDiscontinued by firm2026-10-05
excluded packagepackage63629-154163629-1541-9DDiscontinued by firm2026-10-05

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 3 · 162 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 packagepackage63629-1541-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1541-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1541-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1541-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1541-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1541-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1541-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1541-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1541-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1541-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1541-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1541-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1541-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1541-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1541-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1541-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1541-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1541-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1541-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1541-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1541-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1541-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1541-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1541-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1541-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1541-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1541-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1541-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1541-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1541-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1541-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1541-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1541-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1541-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1541-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1541-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1541-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1541-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1541-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1541-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1541-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1541-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1541-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1541-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1541-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1541-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1541-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1541-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1541-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1541-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1541-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1541-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1541-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1541-9cdf11ea48f46…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
A077996-001ALPRAZOLAMALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORAL2007-01-31
A077996-002ALPRAZOLAMALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORAL2007-01-31
A077996-003ALPRAZOLAMALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORAL2007-01-31
A077996-004ALPRAZOLAMALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORAL2007-01-31

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 22:38:342026-08A077996-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORAL2007-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A077996-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORAL2007-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A077996-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORAL2007-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A077996-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORAL2007-01-3184e616aacf4f…
2026-08-18 06:07:402026-07A077996-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORAL2007-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A077996-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORAL2007-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A077996-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORAL2007-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A077996-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORAL2007-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077996-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORAL2007-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077996-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORAL2007-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077996-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORAL2007-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077996-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORAL2007-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077996-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORAL2007-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077996-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORAL2007-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077996-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORAL2007-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077996-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORAL2007-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077996-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORAL2007-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077996-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORAL2007-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077996-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORAL2007-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077996-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORAL2007-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077996-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORAL2007-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077996-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORAL2007-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077996-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORAL2007-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077996-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORAL2007-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077996-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORAL2007-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077996-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORAL2007-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077996-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORAL2007-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077996-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORAL2007-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077996-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORAL2007-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077996-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORAL2007-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077996-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORAL2007-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077996-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORAL2007-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077996-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORAL2007-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077996-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORAL2007-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077996-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORAL2007-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077996-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORAL2007-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077996-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORAL2007-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077996-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORAL2007-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077996-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORAL2007-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077996-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORAL2007-01-315bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-1541-12021-07-01Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-22021-07-01Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-32021-07-01Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-42021-07-01Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-52021-07-01Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-62021-07-01Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-72021-07-01Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-82021-07-01Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-92021-07-01Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-12019-11-27Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-22019-11-27Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-32019-11-27Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-42019-11-27Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-52019-11-27Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-62019-11-27Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-72019-11-27Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-82019-11-27Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only
63629-1541-92019-11-27Alprazolam Extended-Release Tablets CIV 0.5 mg, 1 mg, 2 mg and 3 mg Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1541-1EA - Each63629-15418b23588f-d794-4184-b666-39f3cc638abb12012-07-24
63629-1541-2EA - Each63629-15414c33b02c-d5f0-4a95-a390-1788bdaa0b2c12012-07-24
63629-1541-3EA - Each63629-1541dbfa7cc7-403b-4409-a425-0b8529bc2a8612012-07-24
63629-1541-4EA - Each63629-1541b840d2d4-6a91-45b2-a6d5-64d67818067212012-07-24
63629-1541-5EA - Each63629-1541b7e00dc9-abff-4ee3-850f-95a0c593694e12012-07-24
63629-1541-6EA - Each63629-154133bb5941-369f-4187-ac73-52400f9e2e8d12012-07-24
63629-1541-7EA - Each63629-1541321370ae-a80a-4de4-bba7-455329cab99212012-07-24

DailyMed Socrata Ingredients#