Home NDC 65162-687 Lorazepam
Product NDC 65162-687
11-digit product format 651620687
Labeler code 65162
Product ID 65162-687_99b5d0cb-3d61-497c-9b51-7d0939f923a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lorazepam
Dosage form CONCENTRATE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA091383
Marketing category ANDA
Marketing start 2010-02-01
Substance LORAZEPAM
Active strength 2 mg/mL
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 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 A091383-001 LORAZEPAM LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091383-001 AA
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 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 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 Lorazepam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORAZEPAM 2 mg/mL
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 311376 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 65162-687-84 Lorazepam 30 mL in 1 BOTTLE, DROPPER CONCENTRATE 30 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-687 LORAZEPAM CONCENTRATE [AMNEAL PHARMACEUTICALS LLC] 18 Current NDC, Legacy NDC, 1 package rows 20241030_bf265c2e-ab2f-42e5-96cf-3998eb5a644d.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.
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 65162-687-84 65162068784 30 mL in 1 BOTTLE, DROPPER (65162-687-84) 30 ml 2010-02-01 0000-00-00 No No Current