Home NDC 80425-0465 LORAZEPAM
Product NDC 80425-0465
11-digit product format 804250465
Labeler code 80425
Product ID 80425-0465_2a57e551-1ed3-718f-e063-6394a90a30e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LORAZEPAM
Dosage form TABLET
Route ORAL
Labeler Advanced Rx of Tennessee, LLC
Application ANDA203572
Marketing category ANDA
Marketing start 2024-12-28
Substance LORAZEPAM
Active strength 1 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203572-001 LORAZEPAM LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 A203572-002 LORAZEPAM LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 A203572-003 LORAZEPAM LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 2026-09-14 22:38:34 2026-08 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203572-002 LORAZEPAM 1MG TABLET / ORAL AB 2017-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203572-003 LORAZEPAM 2MG TABLET / ORAL AB 2017-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203572-001 LORAZEPAM 0.5MG TABLET / ORAL AB 2017-12-22 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LORAZEPAM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORAZEPAM 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O26FZP769L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197901 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 80425-0465-1 LORAZEPAM 30 in 1 BOTTLE TABLET 30 1 80425-0465-2 LORAZEPAM 60 in 1 BOTTLE TABLET 60 1 80425-0465-3 LORAZEPAM 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0465 LORAZEPAM TABLET [ADVANCED RX OF TENNESSEE, LLC] 1 Current NDC, 3 package rows 20241229_2a57e549-390b-5482-e063-6394a90aeb3b.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 2 of 2 · 24 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LORAZEPAM LORAZEPAM A-S Medication Solutions 823b1d71-a510-4d34-8015-60b55af23d78 2023-08-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203572 application number: ANDA203572 Lorazepam LORAZEPAM Proficient Rx LP 5b78f7af-0ad8-4fa1-a8c0-9308fe8d9b3a 2022-05-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203572 application number: ANDA203572 Lorazepam LORAZEPAM Aphena Pharma Solutions - Tennessee, LLC 1c956cc1-9217-46e0-80a3-7c811163d3f1 2021-09-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203572 application number: ANDA203572 Lorazepam LORAZEPAM Aphena Pharma Solutions - Tennessee, LLC a4fa14be-cef1-4b4b-b099-abde92f15145 2019-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203572 application number: ANDA203572
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0465-1 80425046501 30 TABLET in 1 BOTTLE (80425-0465-1) 30 tablet 2024-12-28 No No Current 80425-0465-2 80425046502 60 TABLET in 1 BOTTLE (80425-0465-2) 60 tablet 2024-12-28 No No Current 80425-0465-3 80425046503 90 TABLET in 1 BOTTLE (80425-0465-3) 90 tablet 2024-12-28 No No Current