Home NDC 55289-523 Alprazolam
Product NDC 55289-523
11-digit product format 552890523
Labeler code 55289
Product ID 55289-523_2abee2c1-1fa5-af2e-e063-6294a90a6afb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprazolam
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA074909
Marketing category ANDA
Marketing start 1998-03-25
Marketing end 2027-03-19
Substance ALPRAZOLAM
Active strength 2 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074909-001 ALPRAZOLAM ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074909-001 AB
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Alprazolam Active Ingredients# Ingredient, Strength table Ingredient Strength ALPRAZOLAM 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YU55MQ3IZY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197322 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55289-523-01 Alprazolam 100 in 1 BOTTLE, PLASTIC TABLET 100 21 55289-523-30 Alprazolam 30 in 1 BOTTLE, PLASTIC TABLET 30 21 55289-523-40 Alprazolam 40 in 1 BOTTLE, PLASTIC TABLET 40 21 55289-523-60 Alprazolam 60 in 1 BOTTLE, PLASTIC TABLET 60 21 55289-523-90 Alprazolam 90 in 1 BOTTLE, PLASTIC TABLET 90 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-523 ALPRAZOLAM TABLET [PD-RX PHARMACEUTICALS, INC.] 21 Current NDC, Legacy NDC, 5 package rows 20250105_7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed3.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alprazolam ALPRAZOLAM A-S Medication Solutions 3c0cb60f-1c3a-48a6-ad16-f14351548412 2025-07-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074909 application number: ANDA074909 Alprazolam ALPRAZOLAM PD-Rx Pharmaceuticals, Inc. 7538d0d0-346e-4c3e-8f7a-c1cac8ec8ed3 2025-01-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074909 application number: ANDA074909 ndc (product): 55289-523 Alprazolam ALPRAZOLAM Sandoz Inc d9b0e228-17cf-40d7-b62e-5050311c571c 2024-05-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074909 application number: ANDA074909 Alprazolam ALPRAZOLAM Bryant Ranch Prepack b0000772-2514-45a2-a75d-1bbb13c29989 2024-04-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074909 application number: ANDA074909 Alprazolam ALPRAZOLAM Proficient Rx LP 717ce509-f92e-4ec1-a3c6-aeae54d56f4d 2020-08-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 074909 application number: ANDA074909
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 55289-523-01 55289052301 100 TABLET in 1 BOTTLE, PLASTIC (55289-523-01) 100 tablet 2016-03-04 2027-03-19 No No Current 55289-523-30 55289052330 30 TABLET in 1 BOTTLE, PLASTIC (55289-523-30) 30 tablet 2016-03-04 2027-03-19 No No Current 55289-523-40 55289052340 40 TABLET in 1 BOTTLE, PLASTIC (55289-523-40) 40 tablet 2016-03-04 2027-03-19 No No Current 55289-523-60 55289052360 60 TABLET in 1 BOTTLE, PLASTIC (55289-523-60) 60 tablet 2016-03-04 2027-03-19 No No Current 55289-523-90 55289052390 90 TABLET in 1 BOTTLE, PLASTIC (55289-523-90) 90 tablet 2016-03-04 2027-03-19 No No Current