Home NDC 50090-5258 Alprazolam
Product NDC 50090-5258
11-digit product format 500905258
Labeler code 50090
Product ID 50090-5258_c5e046d4-f03c-4a62-ab10-a07219433b33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprazolam
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
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 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.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207507-001 ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET / ORAL 2018-07-09 A207507-002 ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET / ORAL 2018-07-09 A207507-003 ALPRAZOLAM ALPRAZOLAM 1MG TABLET / ORAL 2018-07-09 A207507-004 ALPRAZOLAM ALPRAZOLAM 2MG TABLET / ORAL 2018-07-09
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A207507-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2018-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207507-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2018-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207507-003 ALPRAZOLAM 1MG TABLET / ORAL 2018-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207507-004 ALPRAZOLAM 2MG TABLET / ORAL 2018-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207507-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2018-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207507-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2018-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207507-003 ALPRAZOLAM 1MG TABLET / ORAL 2018-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207507-004 ALPRAZOLAM 2MG TABLET / ORAL 2018-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207507-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2018-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207507-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2018-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207507-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2018-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207507-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2018-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207507-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2018-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207507-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2018-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207507-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2018-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207507-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2018-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207507-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2018-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207507-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2018-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207507-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2018-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207507-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2018-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207507-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2018-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207507-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2018-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207507-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2018-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207507-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2018-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207507-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2018-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207507-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2018-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207507-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2018-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207507-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2018-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207507-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2018-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207507-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2018-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207507-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2018-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207507-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2018-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207507-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2018-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207507-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2018-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207507-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2018-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207507-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2018-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207507-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2018-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207507-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2018-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207507-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2018-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207507-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2018-07-09 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 152 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50090-5258-0 2023-02-07 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 50090-5258-1 2023-02-07 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 50090-5258-2 2023-02-07 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 50090-5258-3 2023-02-07 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 50090-5258-0 2023-01-30 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 50090-5258-1 2023-01-30 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 50090-5258-2 2023-01-30 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 50090-5258-3 2023-01-30 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5258 ALPRAZOLAM TABLET [A-S MEDICATION SOLUTIONS] 14 Legacy NDC 20250406_e06b3bdd-ae21-4503-861e-11412bb7e7ea.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-5258-0 50090525800 90 TABLET in 1 BOTTLE (50090-5258-0) 90 tablet 2020-10-15 0000-00-00 No No Current 50090-5258-1 50090525801 30 TABLET in 1 BOTTLE (50090-5258-1) 30 tablet 2020-10-15 0000-00-00 No No Current 50090-5258-2 50090525802 60 TABLET in 1 BOTTLE (50090-5258-2) 60 tablet 2020-10-15 0000-00-00 No No Current 50090-5258-3 50090525803 100 TABLET in 1 BOTTLE (50090-5258-3) 100 tablet 2020-10-15 0000-00-00 No No Current