ALPRAZOLAM

Product NDC
52959-965
11-digit product format
529590965
Labeler code
52959
Product ID
52959-965_75fcb860-7243-49d6-8ae2-7cd989588e52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
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
2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-965IInactivated by FDA2026-10-05
excluded packagepackage52959-96552959-965-15IInactivated by FDA2026-10-05
excluded packagepackage52959-96552959-965-30IInactivated by FDA2026-10-05
excluded packagepackage52959-96552959-965-60IInactivated by FDA2026-10-05

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 2 · 88 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 packagepackage52959-965-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-965-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-965-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-965-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-965-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-965-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-965-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-965-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-965-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-965-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-965-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-965-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-965-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-965-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-965-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-965-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-965-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-965-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-965-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-965-15302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-965-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-965-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-965-15ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-965-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-965-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-965-150efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-965-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-965-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-965-15ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-965-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-965-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-965-15367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-965-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-965-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-965-15557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-965-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52959-965-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52959-965-158af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52959-965-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52959-965-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52959-965-15834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52959-965-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52959-965-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52959-965-151332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52959-965-601332a3947898…d4bfe170f9cd…

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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
1f9e6d58-49d3-d9c1-e570-4bb0466a2c0bProduct name120140508
a1a11520-f3e2-68fa-8bd9-e80b271ef797Product name120140508
d153678e-a3c8-bad8-cfe0-385656dde0e7Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-965-15ALPRAZOLAMEXTENDED-RELEASE15 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE152
52959-965-30ALPRAZOLAMEXTENDED-RELEASE30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE302
52959-965-60ALPRAZOLAMEXTENDED-RELEASE60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-965-15EA - Each52959-965de9f456b-c326-4640-ab11-ea53a2ebe6d412012-07-24
52959-965-30EA - Each52959-965226ae3e6-21f8-492a-81a3-89cf796fff5312012-07-24
52959-965-60EA - Each52959-965488e043e-bb4b-44b7-b5c3-f3315b4fcb8112012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-965ALPRAZOLAM EXTENDED-RELEASE (ALPRAZOLAM) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 3 package rows20111214_4f6c075f-e2b7-41fa-82c7-eba85cbe27a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN4f6c075f-e2b7-41fa-82c7-eba85cbe27a32
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD4f6c075f-e2b7-41fa-82c7-eba85cbe27a32
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY4f6c075f-e2b7-41fa-82c7-eba85cbe27a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-965-155295909651515 in 1 BOTTLE, PLASTICHistorical
52959-965-305295909653030 in 1 BOTTLE, PLASTICHistorical
52959-965-605295909656060 in 1 BOTTLE, PLASTICHistorical