Xanax

Product NDC
0009-0055
Requested package NDC
0009-0055-46
11-digit product format
000090055
Labeler code
0009
Product ID
0009-0055_f5323eac-81d0-4096-ac15-2f25220c5c28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
PHARMACIA & UPJOHN COMPANY LLC
Application
NDA018276
Marketing category
NDA
Marketing start
1981-10-16
Marketing end
2026-07-31
Substance
ALPRAZOLAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0009-00550009-0055-46DDiscontinued by firm2026-08-03

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…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (package): 0009-0055-46
ndc (product): 0009-0055
ndc11 (package): 00009005546
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-0055-01Xanax100 in 1 BOTTLETABLET10030
0009-0055-03Xanax500 in 1 BOTTLETABLET50030
0009-0055-15Xanax1000 in 1 BOTTLETABLET100030
0009-0055-46Xanax100 in 1 BOTTLE, UNIT-DOSETABLET10030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0055-01EA - Each0009-00551dbe563a-a63e-4a1b-8502-2e0bd2d2264212012-07-24
0009-0055-03EA - Each0009-0055c5f3156d-d750-4c42-af83-78d3eaf4e16f12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0055XANAX (ALPRAZOLAM) TABLET [PHARMACIA & UPJOHN COMPANY LLC]25Current NDC, Legacy NDC, 4 package rows20230831_388e249d-b9b6-44c3-9f8f-880eced0239f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN388e249d-b9b6-44c3-9f8f-880eced0239f30
308048ALPRAZolam 0.5 MG Oral TabletPSN388e249d-b9b6-44c3-9f8f-880eced0239f30
197321ALPRAZolam 1 MG Oral TabletPSN388e249d-b9b6-44c3-9f8f-880eced0239f30
197322ALPRAZolam 2 MG Oral TabletPSN388e249d-b9b6-44c3-9f8f-880eced0239f30
141927Xanax 0.25 MG Oral TabletPSN388e249d-b9b6-44c3-9f8f-880eced0239f30
141928Xanax 0.5 MG Oral TabletPSN388e249d-b9b6-44c3-9f8f-880eced0239f30
214003Xanax 1 MG Oral TabletPSN388e249d-b9b6-44c3-9f8f-880eced0239f30
214004Xanax 2 MG Oral TabletPSN388e249d-b9b6-44c3-9f8f-880eced0239f30
141927alprazolam 0.25 MG Oral Tablet [Xanax]SBD388e249d-b9b6-44c3-9f8f-880eced0239f30
141928alprazolam 0.5 MG Oral Tablet [Xanax]SBD388e249d-b9b6-44c3-9f8f-880eced0239f30
214003alprazolam 1 MG Oral Tablet [Xanax]SBD388e249d-b9b6-44c3-9f8f-880eced0239f30
214004alprazolam 2 MG Oral Tablet [Xanax]SBD388e249d-b9b6-44c3-9f8f-880eced0239f30
308047alprazolam 0.25 MG Oral TabletSCD388e249d-b9b6-44c3-9f8f-880eced0239f30
308048alprazolam 0.5 MG Oral TabletSCD388e249d-b9b6-44c3-9f8f-880eced0239f30
197321alprazolam 1 MG Oral TabletSCD388e249d-b9b6-44c3-9f8f-880eced0239f30
197322alprazolam 2 MG Oral TabletSCD388e249d-b9b6-44c3-9f8f-880eced0239f30
141927Xanax 0.25 MG Oral TabletSY388e249d-b9b6-44c3-9f8f-880eced0239f30
141928Xanax 0.5 MG Oral TabletSY388e249d-b9b6-44c3-9f8f-880eced0239f30
214003Xanax 1 MG Oral TabletSY388e249d-b9b6-44c3-9f8f-880eced0239f30
214004Xanax 2 MG Oral TabletSY388e249d-b9b6-44c3-9f8f-880eced0239f30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0055-4600009005546100 TABLET in 1 BOTTLE, UNIT-DOSE (0009-0055-46) 100 tablet1981-10-160000-00-00NoNoCurrent