ALPRAZOLAM

Product NDC
61919-089
11-digit product format
619190089
Labeler code
61919
Product ID
61919-089_9cad9864-bc8c-94f9-e053-2a95a90a04a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA074112
Marketing category
ANDA
Marketing start
2019-07-12
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
2021-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-089IInactivated by FDA2026-08-17
excluded productproduct61919-089IInactivated by FDA2026-08-17
excluded productproduct61919-089IInactivated by FDA2026-08-17
excluded packagepackage61919-08961919-089-60IInactivated by FDA2026-08-17
excluded packagepackage61919-08961919-089-90IInactivated by FDA2026-08-17
excluded packagepackage61919-08961919-089-30IInactivated by FDA2026-08-17

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 3 · 122 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-089-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-089-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-089-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-089-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-089-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-089-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-089-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-089-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-089-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-089-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-089-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-089-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-089-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-089-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-089-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-089-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-089-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-089-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-089-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-089-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-089-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-089-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-089-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-089-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-089-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-089-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-089-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-089-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-089-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-089-30ad56d346431e…cc804d4bbf1e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074112-001ALPRAZOLAMALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29
A074112-002ALPRAZOLAMALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29
A074112-003ALPRAZOLAMALPRAZOLAM1MGTABLET / ORALAB1995-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A074112-001AB
A074112-002AB
A074112-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-002ALPRAZOLAM0.5MGTABLET / ORALAB1995-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-003ALPRAZOLAM1MGTABLET / ORALAB1995-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074112-001ALPRAZOLAM0.25MGTABLET / ORALAB1995-12-291e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074112-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074112-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074112-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074112-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074112-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074112-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074112-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074112-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074112-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074112-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074112-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074112-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074112-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074112-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074112-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074112-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074112-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074112-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074112-001AB11e350fbaab3a…

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
61919-089-302022-01-28C16284748780-1d6a99b39-51c8-a426-e053-dadaa90af4c2ALPRAZOLAM
61919-089-602020-01-31C16284748780-19d75b9d0-f13c-f424-e053-dadaa90a57ceALPRAZOLAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-089-30ALPRAZOLAM30 in 1 BOTTLETABLET303
61919-089-60XANAX60 in 1 BOTTLETABLET601
61919-089-90XANAX90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-089-30EA - Each61919-089c88cca02-07a1-418e-8206-664ba001b41212019-08-06
61919-089-60EA - Each61919-089667882a5-c780-4ad6-8292-cead7b36890912016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-089ALPRAZOLAM TABLET [DIRECT_RX]3Legacy NDC, 1 package rows20220919_8d801b8a-b203-7ea7-e053-2a95a90a4056.zip
61919-089XANAX (ALPRAZOLAM) TABLET [DIRECT RX]1Legacy NDC, 1 package rows20160603_3450f9b0-2f7f-73ff-e054-00144ff88e88.zip
61919-089XANAX (ALPRAZOLAM) TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190713_8d7e80af-2290-53e4-e053-2a95a90a4e3f.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 · 10 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): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMPD-Rx Pharmaceuticals, Inc.0ffcdbab-17e4-4395-8155-5b6ad00be6c22025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMAdvanced Rx of Tennessee, LLCf667458d-ddda-4e9e-e053-2995a90adb5a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMREMEDYREPACK INC.563e09db-2f3d-4ce8-b356-ae44477be6d02024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMAdvanced Rx Pharmacy of Tennessee, LLCb39e2bc8-b691-0f4e-e053-2995a90a00fd2024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMSandoz Incd9b0e228-17cf-40d7-b62e-5050311c571c2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLCf95f4030-e8e0-416f-951d-c4dac09f386a2023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMAphena Pharma Solutions - Tennessee, LLC54c790c5-2e6c-439d-8e3b-7502c962a5962023-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMProficient Rx LP717ce509-f92e-4ec1-a3c6-aeae54d56f4d2020-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112
AlprazolamALPRAZOLAMProficient Rx LP447efe78-3696-481c-bbae-23199a39ec942019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074112
application number: ANDA074112

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197321ALPRAZolam 1 MG Oral TabletPSN8d801b8a-b203-7ea7-e053-2a95a90a40563
197321alprazolam 1 MG Oral TabletSCD8d801b8a-b203-7ea7-e053-2a95a90a40563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-089-306191900893030 TABLET in 1 BOTTLE (61919-089-30) 30 tablet2019-07-120000-00-00NoNoCurrent
61919-089-606191900896060 in 1 BOTTLEHistorical
61919-089-906191900899090 in 1 BOTTLEHistorical