Alprazolam

Product NDC
65162-812
11-digit product format
651620812
Labeler code
65162
Product ID
65162-812_4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA078387
Marketing category
ANDA
Marketing start
2009-12-03
Substance
ALPRAZOLAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078387-001ALPRAZOLAMALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30
A078387-002ALPRAZOLAMALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30
A078387-003ALPRAZOLAMALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30
A078387-004ALPRAZOLAMALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078387-001AB
A078387-002AB
A078387-003AB
A078387-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078387-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078387-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078387-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078387-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078387-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078387-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078387-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078387-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078387-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2008-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078387-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2008-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078387-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2008-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078387-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2008-05-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078387-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2008-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078387-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2008-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078387-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2008-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078387-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2008-05-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078387-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078387-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078387-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078387-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078387-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078387-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078387-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078387-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078387-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2008-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078387-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2008-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078387-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2008-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078387-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2008-05-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078387-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2008-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078387-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2008-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078387-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2008-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078387-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2008-05-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078387-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2008-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078387-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2008-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078387-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2008-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078387-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2008-05-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078387-001ALPRAZOLAM0.5MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078387-002ALPRAZOLAM1MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078387-003ALPRAZOLAM2MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078387-004ALPRAZOLAM3MGTABLET, EXTENDED RELEASE / ORALAB2008-05-30d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078387-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078387-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078387-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078387-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078387-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078387-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078387-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078387-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078387-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078387-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078387-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078387-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078387-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078387-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078387-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078387-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078387-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078387-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078387-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078387-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078387-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078387-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078387-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078387-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078387-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078387-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078387-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078387-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078387-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078387-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078387-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078387-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078387-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078387-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078387-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078387-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078387-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078387-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078387-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078387-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Alprazolam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPRAZOLAM2 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
433798Internal RxNorm lookup
433799Internal RxNorm lookup
433800Internal RxNorm lookup
433801Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
259387c1-e374-4bc2-9510-5f7f2c60d1a5Available 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
65162-812-03Alprazolam30 in 1 BOTTLETABLET, EXTENDED RELEASE3015
65162-812-06Alprazolam60 in 1 BOTTLETABLET, EXTENDED RELEASE6015
65162-812-50Alprazolam500 in 1 BOTTLETABLET, EXTENDED RELEASE50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-812-06EA - Each65162-812c9ba62a1-adc7-4d7a-90f1-61ae3b737c5212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-812ALPRAZOLAM TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]15Current NDC, Legacy NDC, 3 package rows20240322_259387c1-e374-4bc2-9510-5f7f2c60d1a5.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlprazolamALPRAZOLAMAmneal Pharmaceuticals LLC259387c1-e374-4bc2-9510-5f7f2c60d1a52024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078387
application number: ANDA078387
ndc (product): 65162-812

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN259387c1-e374-4bc2-9510-5f7f2c60d1a515
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN259387c1-e374-4bc2-9510-5f7f2c60d1a515
433799ALPRAZolam 2 MG 24HR Extended Release Oral TabletPSN259387c1-e374-4bc2-9510-5f7f2c60d1a515
433801ALPRAZolam 3 MG 24HR Extended Release Oral TabletPSN259387c1-e374-4bc2-9510-5f7f2c60d1a515
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD259387c1-e374-4bc2-9510-5f7f2c60d1a515
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD259387c1-e374-4bc2-9510-5f7f2c60d1a515
43379924 HR alprazolam 2 MG Extended Release Oral TabletSCD259387c1-e374-4bc2-9510-5f7f2c60d1a515
43380124 HR alprazolam 3 MG Extended Release Oral TabletSCD259387c1-e374-4bc2-9510-5f7f2c60d1a515
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY259387c1-e374-4bc2-9510-5f7f2c60d1a515
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY259387c1-e374-4bc2-9510-5f7f2c60d1a515
433799alprazolam 2 MG 24 HR Extended Release Oral TabletSY259387c1-e374-4bc2-9510-5f7f2c60d1a515
433801alprazolam 3 MG 24 HR Extended Release Oral TabletSY259387c1-e374-4bc2-9510-5f7f2c60d1a515
433798ALPRAZolam 0.5 MG 24HR Extended Release Oral TabletPSN98cc444a-2c39-4410-8020-aded0a8deb811
433800ALPRAZolam 1 MG 24HR Extended Release Oral TabletPSN98cc444a-2c39-4410-8020-aded0a8deb811
433799ALPRAZolam 2 MG 24HR Extended Release Oral TabletPSN98cc444a-2c39-4410-8020-aded0a8deb811
43379824 HR alprazolam 0.5 MG Extended Release Oral TabletSCD98cc444a-2c39-4410-8020-aded0a8deb811
43380024 HR alprazolam 1 MG Extended Release Oral TabletSCD98cc444a-2c39-4410-8020-aded0a8deb811
43379924 HR alprazolam 2 MG Extended Release Oral TabletSCD98cc444a-2c39-4410-8020-aded0a8deb811
433798alprazolam 0.5 MG 24 HR Extended Release Oral TabletSY98cc444a-2c39-4410-8020-aded0a8deb811
433800alprazolam 1 MG 24 HR Extended Release Oral TabletSY98cc444a-2c39-4410-8020-aded0a8deb811
433799alprazolam 2 MG 24 HR Extended Release Oral TabletSY98cc444a-2c39-4410-8020-aded0a8deb811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-812-036516208120330 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-812-03) 2009-12-030000-00-00NoNoCurrent
65162-812-066516208120660 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-812-06) 2009-12-030000-00-00NoNoCurrent
65162-812-5065162081250500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-812-50) 2009-12-030000-00-00NoNoCurrent