ALPRAZOLAM

Product NDC
61919-576
11-digit product format
619190576
Labeler code
61919
Product ID
61919-576_9c591e3e-8c9e-b0c4-e053-2995a90aea13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALPRAZOLAM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA074112
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
ALPRAZOLAM
Active strength
0 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-576IInactivated by FDA2026-08-17
excluded packagepackage61919-57661919-576-60IInactivated by FDA2026-08-17
excluded packagepackage61919-57661919-576-90IInactivated 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 1 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-576-60IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-576-90IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-576-60IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-576-90IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-576-60IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-576-90IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-576-60IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-576-90IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-576-60IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-576-90IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-576-60IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-576-90IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-576-60IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-576-90IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-576-60IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-576-90IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-576-60IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-576-90IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-576-60IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-576-90IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-576-60IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-576-90IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-576-60IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-576-90IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-576-60IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-576-90IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-576-60IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-576-90IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-576-60IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-576-90IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-576-60EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-576-90EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
61919-576-602023-01-30C16284748780-1f386c649-d8df-0266-e053-dadaa90a7c1aALPRAZOLAM
61919-576-902023-01-30C16284748780-1f386c649-d8df-0266-e053-dadaa90a7c1aALPRAZOLAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-576-60ALPRAZOLAM60 in 1 BOTTLETABLET603
61919-576-90ALPRAZOLAM90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-576-60EA - Each61919-57619e0aed4-a6b2-4979-88c4-2f9a1b30b43d12016-09-02
61919-576-90EA - Each61919-576a7113de1-5ab4-478e-8a5d-2f32079c32a512016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALPRAZOLAMACTIVE INGREDIENTYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]1
ALPRAZOLAMACTIVE MOIETYYU55MQ3IZYALPRAZOLAM TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALPRAZOLAM TABLET [DIRECT RX]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0ALPRAZOLAM TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALPRAZOLAM TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALPRAZOLAM TABLET [DIRECT RX]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALPRAZOLAM TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALPRAZOLAM TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-576ALPRAZOLAM TABLET [DIRECT RX]3Legacy NDC, 2 package rows20200118_97d4c3ba-77f2-4a0f-9bc1-688290dde567.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
308047ALPRAZolam 0.25 MG Oral TabletPSN97d4c3ba-77f2-4a0f-9bc1-688290dde5673
308047alprazolam 0.25 MG Oral TabletSCD97d4c3ba-77f2-4a0f-9bc1-688290dde5673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-576-606191905766060 TABLET in 1 BOTTLE (61919-576-60) 60 tablet2015-01-010000-00-00NoNoCurrent
61919-576-906191905769090 TABLET in 1 BOTTLE (61919-576-90) 90 tablet2015-01-010000-00-00NoNoCurrent