Home NDC 70166-260 Lorazepam
Product NDC 70166-260
11-digit product format 701660260
Labeler code 70166
Product ID 70166-260_968adf23-7662-77a3-e053-2995a90aa62b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lorazepam
Dosage form CONCENTRATE
Route ORAL
Labeler Lohxa
Application ANDA091383
Marketing category ANDA
Marketing start 2010-02-01
Marketing end 0000-00-00
Substance LORAZEPAM
Active strength 2 mg/mL
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2020-12-31
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 2 · 76 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091383-001 LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA 2009-12-23 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A091383-001 AA 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091383-001 AA 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091383-001 AA 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A091383-001 AA 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70166-260-03 Lorazepam 0.5 mL in 1 SYRINGE, PLASTIC CONCENTRATE 0.5 1 70166-260-03 Lorazepam 30 in 1 PACKAGE CONCENTRATE 30 1 70166-260-05 Lorazepam 1 mL in 1 SYRINGE, PLASTIC CONCENTRATE 1 1 70166-260-05 Lorazepam 30 in 1 PACKAGE CONCENTRATE 30 1 70166-260-06 Lorazepam 60 in 1 PACKAGE CONCENTRATE 60 1 70166-260-06 Lorazepam 0.5 mL in 1 SYRINGE, PLASTIC CONCENTRATE 0.5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70166-260 LORAZEPAM CONCENTRATE [LOHXA] 1 Legacy NDC, 6 package rows 20191105_093a6f7b-1ea8-4467-bd0f-5f7d29067d32.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lorazepam LORAZEPAM Amneal Pharmaceuticals LLC bf265c2e-ab2f-42e5-96cf-3998eb5a644d 2023-07-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091383 application number: ANDA091383
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 70166-260-03 70166026003 0.5 mL in 1 SYRINGE, PLASTIC 0.5 ml Historical 70166-260-05 70166026005 1 mL in 1 SYRINGE, PLASTIC 1 ml Historical 70166-260-06 70166026006 60 in 1 PACKAGE Historical