Home NDC 50090-5261-3 Alprazolam
Product NDC 50090-5261
Requested package NDC 50090-5261-3
11-digit product format 500905261
Labeler code 50090
Product ID 50090-5261_6ab4f438-9ff6-4749-ab95-1c6bf481d542
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 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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50090-5261-0 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 50090-5261-1 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 50090-5261-2 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 50090-5261-3 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 50090-5261-0 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 50090-5261-1 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 50090-5261-2 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 50090-5261-3 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 50090-5261 ALPRAZOLAM TABLET [A-S MEDICATION SOLUTIONS] 8 Legacy NDC 20230513_d2ff7095-ee9a-4034-854f-efcfec47b284.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-5261-3 50090526103 90 TABLET in 1 BOTTLE (50090-5261-3) 90 tablet 2020-10-15 0000-00-00 No No Current