Alprazolam

Product NDC
71335-9666
Requested package NDC
71335-9666-7
11-digit product format
713359666
Labeler code
71335
Product ID
71335-9666_b93d3341-c70b-4da1-bef6-6c5106c21dcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203346
Marketing category
ANDA
Marketing start
2015-07-31
Substance
ALPRAZOLAM
Active strength
.5 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 43.

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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-3184e616aacf4f…
2026-09-14 22:38:342026-08A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-3184e616aacf4f…
2026-08-18 06:07:402026-07A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-001ALPRAZOLAM0.25MGTABLET / ORALAB2015-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-002ALPRAZOLAM0.5MGTABLET / ORALAB2015-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-003ALPRAZOLAM1MGTABLET / ORALAB2015-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-004ALPRAZOLAM2MGTABLET / ORALAB2015-07-315bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203346-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203346-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203346-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A203346-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A203346-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203346-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203346-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203346-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203346-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203346-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203346-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203346-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203346-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203346-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203346-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203346-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM.5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
2bd0d4c6-0fde-46f2-bb13-da25d50427dfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2ffbe5ef-58ff-88b9-e291-045e0f861f4fProduct name420180827
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
71335-9666-0Alprazolam10 in 1 BOTTLETABLET10106
71335-9666-1Alprazolam15 in 1 BOTTLETABLET15106
71335-9666-2Alprazolam30 in 1 BOTTLETABLET30106
71335-9666-3Alprazolam20 in 1 BOTTLETABLET20106
71335-9666-4Alprazolam100 in 1 BOTTLETABLET100106
71335-9666-5Alprazolam90 in 1 BOTTLETABLET90106
71335-9666-6Alprazolam60 in 1 BOTTLETABLET60106
71335-9666-7Alprazolam120 in 1 BOTTLETABLET120106
71335-9666-8Alprazolam28 in 1 BOTTLETABLET28106
71335-9666-9Alprazolam2 in 1 BOTTLETABLET2106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9666-1EA - Each71335-9666cbb64355-56a2-4c15-9d97-e033a072936512023-09-05
71335-9666-2EA - Each71335-9666ac185d66-c68d-4b51-a58d-85f9d5020ab812025-05-14
71335-9666-5EA - Each71335-9666a1b4c8a1-eaad-4c28-a05e-57f24235231c12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9666ALPRAZOLAM TABLET [BRYANT RANCH PREPACK]104Current NDC, 10 package rows20240824_2bd0d4c6-0fde-46f2-bb13-da25d50427df.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
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
ndc (package): 71335-9666-7
ndc (product): 71335-9666
ndc11 (package): 71335966607
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSN2bd0d4c6-0fde-46f2-bb13-da25d50427df106
308048alprazolam 0.5 MG Oral TabletSCD2bd0d4c6-0fde-46f2-bb13-da25d50427df106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9666-771335966607120 TABLET in 1 BOTTLE (71335-9666-7) 120 tablet2023-03-27NoNoCurrent