Home NDC 68071-5243 Alprazolam
Product NDC 68071-5243
11-digit product format 680715243
Labeler code 68071
Product ID 68071-5243_e80466c7-3132-1e86-e053-2a95a90a2ebc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprazolam
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA207507
Marketing category ANDA
Marketing start 2018-07-09
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 2023-12-31
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68071-5243-3 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68071-5243-3 f5e01cc5f278…a2eaf40c39c3…
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-5243 ALPRAZOLAM TABLET [NUCARE PHARMACEUTICALS,INC.] 4 Legacy NDC 20240822_a45ba448-d77b-7bfd-e053-2a95a90aa44b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-5243-3 68071524303 30 TABLET in 1 BOTTLE (68071-5243-3) 30 tablet 2020-04-28 0000-00-00 No No Current