Home NDC 67296-0721-1 Alprazolam
Product NDC 67296-0721
Requested package NDC 67296-0721-1
11-digit product format 672960721
Labeler code 67296
Product ID 67296-0721_9c9af7ee-606f-5314-e053-2995a90a8f25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprazolam
Dosage form TABLET
Route ORAL
Labeler RedPharm Drug, Inc.
Application ANDA074174
Marketing category ANDA
Marketing start 2007-03-28
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 2021-12-31
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 · 19 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A074174-001 ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET / ORAL AB 1993-10-19 A074174-002 ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET / ORAL AB 1993-10-19 A074174-003 ALPRAZOLAM ALPRAZOLAM 1MG TABLET / ORAL AB 1993-10-19 A074174-004 ALPRAZOLAM ALPRAZOLAM 2MG TABLET / ORAL AB 1993-10-19
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 · 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 A074174-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 1993-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074174-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 1993-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074174-003 ALPRAZOLAM 1MG TABLET / ORAL AB 1993-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074174-004 ALPRAZOLAM 2MG TABLET / ORAL AB 1993-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074174-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 1993-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074174-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 1993-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074174-003 ALPRAZOLAM 1MG TABLET / ORAL AB 1993-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074174-004 ALPRAZOLAM 2MG TABLET / ORAL AB 1993-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074174-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 1993-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074174-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 1993-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074174-003 ALPRAZOLAM 1MG TABLET / ORAL AB 1993-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074174-004 ALPRAZOLAM 2MG TABLET / ORAL AB 1993-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074174-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 1993-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074174-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 1993-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074174-003 ALPRAZOLAM 1MG TABLET / ORAL AB 1993-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074174-004 ALPRAZOLAM 2MG TABLET / ORAL AB 1993-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074174-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 1993-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074174-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 1993-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074174-003 ALPRAZOLAM 1MG TABLET / ORAL AB 1993-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074174-004 ALPRAZOLAM 2MG TABLET / ORAL AB 1993-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074174-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 1993-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074174-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 1993-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074174-003 ALPRAZOLAM 1MG TABLET / ORAL AB 1993-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074174-004 ALPRAZOLAM 2MG TABLET / ORAL AB 1993-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074174-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 1993-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074174-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 1993-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074174-003 ALPRAZOLAM 1MG TABLET / ORAL AB 1993-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074174-004 ALPRAZOLAM 2MG TABLET / ORAL AB 1993-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074174-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 1993-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074174-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 1993-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074174-003 ALPRAZOLAM 1MG TABLET / ORAL AB 1993-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074174-004 ALPRAZOLAM 2MG TABLET / ORAL AB 1993-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074174-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 1993-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074174-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 1993-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074174-003 ALPRAZOLAM 1MG TABLET / ORAL AB 1993-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074174-004 ALPRAZOLAM 2MG TABLET / ORAL AB 1993-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074174-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 1993-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074174-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 1993-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074174-003 ALPRAZOLAM 1MG TABLET / ORAL AB 1993-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074174-004 ALPRAZOLAM 2MG TABLET / ORAL AB 1993-10-19 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 148 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67296-0721-1 Alprazolam 20 in 1 BOTTLE TABLET 20 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-0721 ALPRAZOLAM TABLET [REDPHARM DRUG, INC.] 2 Legacy NDC, 1 package rows 20200121_4171e196-8f22-276a-e054-00144ff8d46c.zip
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 ANI Pharmaceuticals, Inc. 38428a1b-718c-49cc-94ae-2e3644ba6256 2023-06-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074174 application number: ANDA074174
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67296-0721-1 67296072101 20 TABLET in 1 BOTTLE (67296-0721-1) 20 tablet 2007-03-28 0000-00-00 No No Current