FDA.reportPublic FDA data

Alprazolam

Product NDC
87063-173
11-digit product format
870630173
Labeler code
87063
Product ID
87063-173_50a7293f-d49a-aff7-e063-6294a90a4c19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
ASCLEMED USA INC.
Application
ANDA203346
Marketing category
ANDA
Marketing start
2015-07-31
Substance
ALPRAZOLAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A203346-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31
A203346-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31
A203346-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORALAB2015-07-31
A203346-004ALPRAZOLAMALPRAZOLAM2MGTABLET / ORALAB2015-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203346-001AB
A203346-002AB
A203346-003AB
A203346-004AB

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 22:54:322026-06A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31a50c72e98297…
2026-08-01 22:54:322026-06A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31a50c72e98297…
2026-08-01 22:54:322026-06A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-31a50c72e98297…
2026-08-01 22:54:322026-06A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203346-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203346-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A203346-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A203346-004AB1a50c72e98297…

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMClinical Solutions Wholesale, LLC0cf8b567-201b-44fa-8fd3-c74023aff44f2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.4203d3fe-916e-41af-9daf-f58f4fed6f9c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMSt. Mary's Medical Park Pharmacyfc5fe795-6b41-aecf-e053-6394a90af5622026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMBryant Ranch Prepack68d8b8d1-00a4-42c4-a796-90211fee1a6d2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMCoupler LLC5111e57d-8920-6861-e063-6294a90a21942026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMASCLEMED USA INC.8d76a554-7ed1-4c93-a5ea-30898aec0aa12026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
ndc (product): 87063-173
AlprazolamALPRAZOLAMCoupler LLC509a8a86-d61c-3f05-e063-6394a90a52ca2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMBryant Ranch Prepack2bd0d4c6-0fde-46f2-bb13-da25d50427df2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMBryant Ranch Prepackd8364af1-d23e-4cd7-9a81-077ae97a951a2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMBryant Ranch Prepack0e2644fa-8334-4209-a63d-2466b5ab55b42026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
Alprazolam C-IVALPRAZOLAM C-IVDirect_Rxf6dd8005-1d50-41bc-e053-6394a90ac45b2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMProficient Rx LPc6795ed8-af28-41f4-b85b-48e1fe9d03692026-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMPreferredPharmaceuticals Inc.dc130aae-4510-4de7-a750-4a144e88208d2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMPreferred Pharmaceuticals Inc.73c1d1dc-ade2-4bb4-b109-83bd63acd15c2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMPreferred Pharmaceuticals Inc.78682252-e448-4b20-b49d-27c2c70e4cb32026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMNorthwind Health Company, LLC25174ee5-a86e-ab97-e063-6394a90acd872025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMAurobindo Pharma Limitedd2fd0b3e-9b78-44d0-82a6-96d6c62387502025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMAvPAK3fa14fa4-45a7-6ef4-e063-6394a90a1dcd2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
Alprazolam C-IVALPRAZOLAM C-IVDirect_Rxf6dd0e94-4a79-769f-e053-6394a90a5ae62025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346
AlprazolamALPRAZOLAMNuCare Pharmaceuticals, Inc.315b5782-969a-4324-e063-6394a90acf372025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203346
application number: ANDA203346

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam
Listing expiration
2027-12-31

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197321Internal RxNorm lookup
197322Internal 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
8d76a554-7ed1-4c93-a5ea-30898aec0aa1Available 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
87063-173-01Alprazolam100 in 1 BOTTLETABLET1001
87063-173-30Alprazolam30 in 1 BOTTLETABLET301
87063-173-60Alprazolam60 in 1 BOTTLETABLET601
87063-173-90Alprazolam90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308047ALPRAZolam 0.25 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308048ALPRAZolam 0.5 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197321ALPRAZolam 1 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197322ALPRAZolam 2 MG Oral TabletPSN8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308047alprazolam 0.25 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
308048alprazolam 0.5 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197321alprazolam 1 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11
197322alprazolam 2 MG Oral TabletSCD8d76a554-7ed1-4c93-a5ea-30898aec0aa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87063-173-0187063017301100 TABLET in 1 BOTTLE (87063-173-01) 100 tablet2026-04-30NoNoCurrent
87063-173-308706301733030 TABLET in 1 BOTTLE (87063-173-30) 30 tablet2026-04-30NoNoCurrent
87063-173-608706301736060 TABLET in 1 BOTTLE (87063-173-60) 60 tablet2026-04-30NoNoCurrent
87063-173-908706301739090 TABLET in 1 BOTTLE (87063-173-90) 90 tablet2026-04-30NoNoCurrent