FDA.reportPublic FDA data

Alprazolam

Product NDC
66267-564
Requested package NDC
66267-564-90
11-digit product format
662670564
Labeler code
66267
Product ID
66267-564_b8a7b0c8-25da-5d2c-e053-2995a90a0006
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA074909
Marketing category
ANDA
Marketing start
1998-03-25
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
2022-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage66267-56466267-564-90IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074909-001ALPRAZOLAMALPRAZOLAM2MGTABLET / ORALAB1998-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074909-001AB

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 22:54:322026-06A074909-001ALPRAZOLAM2MGTABLET / ORALAB1998-03-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074909-001AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMA-S Medication Solutions3c0cb60f-1c3a-48a6-ad16-f143515484122025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed32025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
AlprazolamALPRAZOLAMSandoz Incd9b0e228-17cf-40d7-b62e-5050311c571c2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
AlprazolamALPRAZOLAMBryant Ranch Prepackb0000772-2514-45a2-a75d-1bbb13c299892024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909
AlprazolamALPRAZOLAMProficient Rx LP717ce509-f92e-4ec1-a3c6-aeae54d56f4d2020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074909
application number: ANDA074909

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-564-302023-01-30C16284748780-1f386c649-9f3a-0266-e053-dadaa90a7c1aAlprazolam Tablets, USP
66267-564-602023-01-30C16284748780-1f386c649-9f3a-0266-e053-dadaa90a7c1aAlprazolam Tablets, USP
66267-564-902023-01-30C16284748780-1f386c649-9f3a-0266-e053-dadaa90a7c1aAlprazolam Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-564-30Alprazolam30 in 1 BOTTLETABLET302
66267-564-60Alprazolam60 in 1 BOTTLETABLET602
66267-564-90Alprazolam90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-564ALPRAZOLAM TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 3 package rows20210112_60bb0c7a-5ab1-2ba8-e053-2a91aa0a1ec9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197322ALPRAZolam 2 MG Oral TabletPSN60bb0c7a-5ab1-2ba8-e053-2a91aa0a1ec92
197322alprazolam 2 MG Oral TabletSCD60bb0c7a-5ab1-2ba8-e053-2a91aa0a1ec92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-564-906626705649090 TABLET in 1 BOTTLE (66267-564-90) 90 tablet2017-12-190000-00-00NoNoCurrent