Home NDC 61919-447 ALPRAZOLAM
Product NDC 61919-447
11-digit product format 619190447
Labeler code 61919
Product ID 61919-447_87d379da-103c-c751-e053-2995a90a56de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ALPRAZOLAM
Dosage form TABLET
Route ORAL
Labeler DIRECT RX
Application ANDA078491
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]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 36 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 A078491-001 ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET / ORAL 2008-09-25 A078491-002 ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET / ORAL 2008-09-25 A078491-003 ALPRAZOLAM ALPRAZOLAM 1MG TABLET / ORAL 2008-09-25 A078491-004 ALPRAZOLAM ALPRAZOLAM 2MG TABLET / ORAL 2008-12-12
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 A078491-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2008-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078491-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2008-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078491-003 ALPRAZOLAM 1MG TABLET / ORAL 2008-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078491-004 ALPRAZOLAM 2MG TABLET / ORAL 2008-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078491-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2008-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078491-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2008-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078491-003 ALPRAZOLAM 1MG TABLET / ORAL 2008-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078491-004 ALPRAZOLAM 2MG TABLET / ORAL 2008-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078491-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2008-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078491-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2008-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078491-003 ALPRAZOLAM 1MG TABLET / ORAL 2008-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078491-004 ALPRAZOLAM 2MG TABLET / ORAL 2008-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078491-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2008-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078491-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2008-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078491-003 ALPRAZOLAM 1MG TABLET / ORAL 2008-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078491-004 ALPRAZOLAM 2MG TABLET / ORAL 2008-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078491-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2008-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078491-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2008-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078491-003 ALPRAZOLAM 1MG TABLET / ORAL 2008-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078491-004 ALPRAZOLAM 2MG TABLET / ORAL 2008-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078491-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2008-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078491-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2008-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078491-003 ALPRAZOLAM 1MG TABLET / ORAL 2008-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078491-004 ALPRAZOLAM 2MG TABLET / ORAL 2008-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078491-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2008-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078491-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2008-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078491-003 ALPRAZOLAM 1MG TABLET / ORAL 2008-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078491-004 ALPRAZOLAM 2MG TABLET / ORAL 2008-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078491-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2008-09-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078491-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2008-09-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078491-003 ALPRAZOLAM 1MG TABLET / ORAL 2008-09-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078491-004 ALPRAZOLAM 2MG TABLET / ORAL 2008-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078491-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2008-09-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078491-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2008-09-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078491-003 ALPRAZOLAM 1MG TABLET / ORAL 2008-09-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078491-004 ALPRAZOLAM 2MG TABLET / ORAL 2008-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078491-001 ALPRAZOLAM 0.25MG TABLET / ORAL 2008-09-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078491-002 ALPRAZOLAM 0.5MG TABLET / ORAL 2008-09-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078491-003 ALPRAZOLAM 1MG TABLET / ORAL 2008-09-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078491-004 ALPRAZOLAM 2MG TABLET / ORAL 2008-12-12 d06236e962d9…
Observed Orange Book normalized TE history#