Home NDC 71335-0920 Alprazolam
Product NDC 71335-0920
11-digit product format 713350920
Labeler code 71335
Product ID 71335-0920_acde6be9-207c-4954-b94d-7c7777a9188e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alprazolam
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
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 1 .
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.
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 2026-08-01 22:54:32 2026-06 A074909-001 ALPRAZOLAM 2MG TABLET / ORAL AB 1998-03-25 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A074909-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 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 ndc (product): 71335-0920 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
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 71335-0920-1 2024-05-16 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-2 2024-05-16 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-3 2024-05-16 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-4 2024-05-16 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-5 2024-05-16 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-6 2024-05-16 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-7 2024-05-16 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-1 2024-01-30 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-2 2024-01-30 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-3 2024-01-30 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-4 2024-01-30 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-5 2024-01-30 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-6 2024-01-30 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981 71335-0920-7 2024-01-30 C162847 48780-1 1030e365-479b-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use ALPRAZOLAM TABLETS safely and effectively. See full prescribing information for ALPRAZOLAM TABLETS. ALPRAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1981
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0920 ALPRAZOLAM TABLET [BRYANT RANCH PREPACK] 9 Current NDC, Legacy NDC, 7 package rows 20240518_b0000772-2514-45a2-a75d-1bbb13c29989.zip
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 71335-0920-1 71335092001 30 TABLET in 1 BOTTLE (71335-0920-1) 30 tablet 2018-08-02 2027-03-19 No No Current 71335-0920-2 71335092002 60 TABLET in 1 BOTTLE (71335-0920-2) 60 tablet 2021-12-28 2027-03-19 No No Current 71335-0920-3 71335092003 90 TABLET in 1 BOTTLE (71335-0920-3) 90 tablet 2021-12-28 2027-03-19 No No Current 71335-0920-4 71335092004 100 TABLET in 1 BOTTLE (71335-0920-4) 100 tablet 2021-12-28 2027-03-19 No No Current 71335-0920-5 71335092005 10 TABLET in 1 BOTTLE (71335-0920-5) 10 tablet 2021-12-28 2027-03-19 No No Current 71335-0920-6 71335092006 120 TABLET in 1 BOTTLE (71335-0920-6) 120 tablet 2021-12-28 2027-03-19 No No Current 71335-0920-7 71335092007 40 TABLET in 1 BOTTLE (71335-0920-7) 40 tablet 2021-12-28 2027-03-19 No No Current