Alprazolam

Product NDC
53002-0340
Requested package NDC
53002-0340-2
11-digit product format
530020340
Labeler code
53002
Product ID
53002-0340_d0a9dd87-1579-4ebd-97b5-e1ea62d95f97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
NDA018276
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1981-10-16
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
2 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-034053002-0340-2IInactivated by FDA2026-08-03

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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
N018276-001XANAXALPRAZOLAM0.25MGTABLET / ORALABRLD, Approved before 1982
N018276-002XANAXALPRAZOLAM0.5MGTABLET / ORALABRLD, Approved before 1982
N018276-003XANAXALPRAZOLAM1MGTABLET / ORALABRLD, RS, Approved before 1982
N018276-004XANAXALPRAZOLAM2MGTABLET / ORALABRLD1985-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N018276-001AB
N018276-002AB
N018276-003AB
N018276-004AB

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 UTC2026-02N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-004XANAX2MGTABLET / ORALABRLD1985-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-004XANAX2MGTABLET / ORALABRLD1985-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-004XANAX2MGTABLET / ORALABRLD1985-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-004XANAX2MGTABLET / ORALABRLD1985-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-004XANAX2MGTABLET / ORALABRLD1985-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-004XANAX2MGTABLET / ORALABRLD1985-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-004XANAX2MGTABLET / ORALABRLD1985-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-004XANAX2MGTABLET / ORALABRLD1985-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-004XANAX2MGTABLET / ORALABRLD1985-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-004XANAX2MGTABLET / ORALABRLD1985-11-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018276-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018276-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018276-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018276-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018276-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018276-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018276-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018276-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018276-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018276-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018276-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018276-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018276-004AB1d06236e962d9…

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
53002-0340-22025-01-30These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-32025-01-30These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-22023-06-07These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-32023-06-07These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-22023-01-30These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-32023-01-30These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-22020-12-16These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-32020-12-16These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-22020-01-31These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981
53002-0340-32020-01-31These highlights do not include all the information needed to use ALPRAZOLAM safely and effectively. See full prescribing information for ALPRAZOLAM. ALPRAZOLAM (alprazolam) tablets, for oral use, CIV Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0340-2Alprazolam20 in 1 BOTTLETABLET205
53002-0340-3Alprazolam30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0340ALPRAZOLAM TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_88de14a4-e8a5-49bd-a480-b19fefbac15c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMMylan Pharmaceuticals Inc.13930c94-d83a-414f-be35-b1fef35f738d2025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
XanaxALPRAZOLAMViatris Specialty LLCbb5cf72e-3a41-41a8-9a38-80f974eca33f2024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
AlprazolamALPRAZOLAMAsclemed USA, Inc.e3245259-024f-4bd9-9ec6-94aa11febfd72024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
AlprazolamALPRAZOLAMProficient Rx LP60c90b4b-174f-4fd2-b65f-fc166c16bdc12023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
AlprazolamALPRAZOLAMProficient Rx LP10de2b3b-3b3f-4a5a-a9e7-a8401f53b8cc2023-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
XanaxALPRAZOLAMPHARMACIA & UPJOHN COMPANY LLC388e249d-b9b6-44c3-9f8f-880eced0239f2023-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
AlprazolamALPRAZOLAMProficient Rx LP4579facb-b225-4108-a5ef-dada926ef7cf2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
AlprazolamALPRAZOLAMProficient Rx LPf6990b57-7011-4cdf-8abc-1794e2e0c7f12019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC964d7f43-34a6-45af-a95f-3b9ade17c6a52018-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018276
application number: NDA018276

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197322ALPRAZolam 2 MG Oral TabletPSN88de14a4-e8a5-49bd-a480-b19fefbac15c5
197322alprazolam 2 MG Oral TabletSCD88de14a4-e8a5-49bd-a480-b19fefbac15c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0340-25300203400220 TABLET in 1 BOTTLE (53002-0340-2) 20 tablet2017-10-010000-00-00NoNoCurrent