Home NDC 67253-903 Alprazolam
Product NDC 67253-903
11-digit product format 672530903
Labeler code 67253
Product ID 67253-903_f7f35ad6-705d-4e9e-9ace-6c5eedf6459e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprazolam
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical
Application ANDA074174
Marketing category ANDA
Marketing start 2007-03-28
Marketing end 2022-05-31
Substance ALPRAZOLAM
Active strength 2 mg/1
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 0000-00-00
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 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALPRAZOLAM ACTIVE INGREDIENT YU55MQ3IZY ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 ALPRAZOLAM ACTIVE INGREDIENT YU55MQ3IZY ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 ALPRAZOLAM ACTIVE MOIETY YU55MQ3IZY ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 ALPRAZOLAM ACTIVE MOIETY YU55MQ3IZY ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ALPRAZOLAM TABLET [DAVA PHARMACEUTICALS, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ALPRAZOLAM TABLET [PREFERRED PHARMACEUTICALS INC.] 2 ALPRAZOLAM ACTIVE INGREDIENT YU55MQ3IZY ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 ALPRAZOLAM ACTIVE MOIETY YU55MQ3IZY ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ALPRAZOLAM TABLET [AIDAREX PHARMACEUTICALS LLC] 1
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 67253-903-10 67253090310 100 TABLET in 1 BOTTLE (67253-903-10) 100 tablet 2007-03-28 2022-05-31 No No Current 67253-903-50 67253090350 500 TABLET in 1 BOTTLE (67253-903-50) 500 tablet 2007-03-28 2022-05-31 No No Current