FDA.reportPublic FDA data

Xanax

Product NDC
0009-0055
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0009-0055DDiscontinued by firm2026-08-03
excluded packagepackage0009-00550009-0055-01DDiscontinued by firm2026-08-03
excluded packagepackage0009-00550009-0055-03DDiscontinued by firm2026-08-03
excluded packagepackage0009-00550009-0055-15DDiscontinued by firm2026-08-03
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N018276-001XANAX0.25MGTABLET / ORALABRLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N018276-002XANAX0.5MGTABLET / ORALABRLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N018276-003XANAX1MGTABLET / ORALABRLD, RS, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N018276-004XANAX2MGTABLET / ORALABRLD1985-11-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N018276-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N018276-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N018276-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N018276-004AB1a50c72e98297…

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 (product): 0009-0055
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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYXANAX (ALPRAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]11
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYXANAX (ALPRAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]11
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0XANAX (ALPRAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKXANAX (ALPRAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8XANAX (ALPRAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]11
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GXANAX (ALPRAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30XANAX (ALPRAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]11
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MXANAX (ALPRAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4XANAX (ALPRAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]11
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUXANAX (ALPRAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJXANAX (ALPRAZOLAM) TABLET [PHARMACIA AND UPJOHN COMPANY]11

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
0009-0055-0100009005501100 TABLET in 1 BOTTLE (0009-0055-01) 100 tablet1981-10-162026-07-31NoNoCurrent
0009-0055-0300009005503500 TABLET in 1 BOTTLE (0009-0055-03) 500 tablet1981-10-162026-07-31NoNoCurrent
0009-0055-15000090055151000 TABLET in 1 BOTTLE (0009-0055-15) 1000 tablet1981-10-160000-00-00NoNoCurrent
0009-0055-4600009005546100 TABLET in 1 BOTTLE, UNIT-DOSE (0009-0055-46) 100 tablet1981-10-160000-00-00NoNoCurrent