FDA.reportPublic FDA data

Xanax

Product NDC
0009-0090
Requested package NDC
0009-0090-13
11-digit product format
000090090
Labeler code
0009
Product ID
0009-0090_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
2026-12-31
Substance
ALPRAZOLAM
Active strength
1 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 packagepackage0009-00900009-0090-13DDiscontinued 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 (package): 0009-0090-13
ndc (product): 0009-0090
ndc11 (package): 00009009013
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

Additional Listing Data#

Finished product
Yes
Brand name base
Xanax

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YU55MQ3IZYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
141927Internal RxNorm lookup
141928Internal RxNorm lookup
197321Internal RxNorm lookup
197322Internal RxNorm lookup
214003Internal RxNorm lookup
214004Internal RxNorm lookup
308047Internal RxNorm lookup
308048Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
388e249d-b9b6-44c3-9f8f-880eced0239fAvailable on FDA.report

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
0009-0090-01Xanax100 in 1 BOTTLETABLET10030
0009-0090-04Xanax500 in 1 BOTTLETABLET50030
0009-0090-13Xanax1000 in 1 BOTTLETABLET100030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0090-01EA - Each0009-009045953337-8155-4597-98a2-38b99ddd3e1512012-07-24
0009-0090-04EA - Each0009-009065db67ca-194d-4132-867f-c3e87d19372f12012-07-24

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
0009-0090XANAX (ALPRAZOLAM) TABLET [PHARMACIA & UPJOHN COMPANY LLC]25Current NDC, Legacy NDC, 3 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
0009-0090-13000090090131000 TABLET in 1 BOTTLE (0009-0090-13) 1000 tablet1981-10-160000-00-00NoNoCurrent