Home NDC 55700-491 Alprazolam
Product NDC 55700-491
11-digit product format 557000491
Labeler code 55700
Product ID 55700-491_48d6cb0f-e347-4649-8628-15434b4373c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprazolam
Dosage form TABLET
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA200739
Marketing category ANDA
Marketing start 2017-01-27
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 2019-12-31
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A200739-001 ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 A200739-002 ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 A200739-003 ALPRAZOLAM ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 A200739-004 ALPRAZOLAM ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 172 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 2026-09-14 22:38:34 2026-08 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 5 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alprazolam ALPRAZOLAM Natco Pharma USA LLC b3c55877-2538-4892-bdb1-d618c643d29c 2026-01-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200739 application number: ANDA200739