Alprazolam

Product NDC
51991-706
11-digit product format
519910706
Labeler code
51991
Product ID
51991-706_94163352-f78e-400a-b7da-b3075e9213eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprazolam
Dosage form
TABLET
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA207507
Marketing category
ANDA
Marketing start
2018-07-09
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
1 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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51991-706DDiscontinued by firm2026-08-07
excluded packagepackage51991-70651991-706-01DDiscontinued by firm2026-08-07
excluded packagepackage51991-70651991-706-05DDiscontinued by firm2026-08-07
excluded packagepackage51991-70651991-706-10DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51991-706-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51991-706-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51991-706-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51991-706-05f5e01cc5f278…a2eaf40c39c3…

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
A207507-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORAL2018-07-09
A207507-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORAL2018-07-09
A207507-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORAL2018-07-09
A207507-004ALPRAZOLAMALPRAZOLAM2MGTABLET / ORAL2018-07-09

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207507-001ALPRAZOLAM0.25MGTABLET / ORAL2018-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207507-002ALPRAZOLAM0.5MGTABLET / ORAL2018-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207507-003ALPRAZOLAM1MGTABLET / ORAL2018-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207507-004ALPRAZOLAM2MGTABLET / ORAL2018-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-001ALPRAZOLAM0.25MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-002ALPRAZOLAM0.5MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-003ALPRAZOLAM1MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207507-004ALPRAZOLAM2MGTABLET / ORAL2018-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207507-001ALPRAZOLAM0.25MGTABLET / ORALAB2018-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-002ALPRAZOLAM0.5MGTABLET / ORALAB2018-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-003ALPRAZOLAM1MGTABLET / ORALAB2018-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-004ALPRAZOLAM2MGTABLET / ORALAB2018-07-09d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A207507-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207507-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207507-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207507-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207507-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207507-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207507-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207507-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207507-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207507-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207507-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207507-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207507-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207507-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207507-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207507-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207507-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207507-004AB1301d65b070ca…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-706-01EA - Each51991-70627f6dae5-5f95-4c1d-8aad-1f021ad57e3912018-09-05
51991-706-05EA - Each51991-70625d3cb57-b700-42f5-973c-58107f1a4aeb12018-09-05
51991-706-10EA - Each51991-706e51cf44e-0f2d-4579-b69c-19c223ee2d4312018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-706ALPRAZOLAM TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]6Legacy NDC20230728_67f66894-addc-4e92-855a-c9ae03a5c2c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308048ALPRAZolam 0.5 MG Oral TabletPSNac886819-5bf1-2294-e053-2995a90ad0587
197321ALPRAZolam 1 MG Oral TabletPSNac886819-5bf1-2294-e053-2995a90ad0587
197322ALPRAZolam 2 MG Oral TabletPSNac886819-5bf1-2294-e053-2995a90ad0587
308048alprazolam 0.5 MG Oral TabletSCDac886819-5bf1-2294-e053-2995a90ad0587
197321alprazolam 1 MG Oral TabletSCDac886819-5bf1-2294-e053-2995a90ad0587
197322alprazolam 2 MG Oral TabletSCDac886819-5bf1-2294-e053-2995a90ad0587

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-706-0151991070601100 TABLET in 1 BOTTLE (51991-706-01) 100 tablet2018-07-090000-00-00NoNoCurrent
51991-706-0551991070605500 TABLET in 1 BOTTLE (51991-706-05) 500 tablet2018-07-090000-00-00NoNoCurrent
51991-706-10519910706101000 TABLET in 1 BOTTLE (51991-706-10) 1000 tablet2018-07-090000-00-00NoNoCurrent