Home NDC 70518-3188 Lorazepam
Product NDC 70518-3188
11-digit product format 705183188
Labeler code 70518
Product ID 70518-3188_4d23dd7d-c54a-aec6-e063-6394a90a7b25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lorazepam
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA072928
Marketing category ANDA
Marketing start 2021-08-10
Substance LORAZEPAM
Active strength 2 mg/1
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 1 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-3188-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-3188-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-3188-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-3188-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-3188-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-3188-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-3188-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-3188-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-3188-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-3188-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-3188-0 367a005e9d99…383a685ebd0f…
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 A072928-001 LORAZEPAM LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072928-001 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 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072928-001 LORAZEPAM 2MG TABLET / ORAL AB 1991-10-31 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LORAZEPAM 2 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 197902 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# DailyMed Package Descriptions# 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 Lorazepam LORAZEPAM REMEDYREPACK INC. ed37d304-04cf-43ec-a58d-d72002ff889b 2026-08-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072928 application number: ANDA072928 ndc (product): 70518-3188 Lorazepam LORAZEPAM Unit Dose Solutions, Inc. 551a1b7f-d342-2c53-e063-6394a90a9a2a 2026-06-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072928 application number: ANDA072928 Lorazepam LORAZEPAM Aphena Pharma Solutions - Tennessee, LLC 3c20c89f-c8c3-43b3-837e-da413f449795 2025-05-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072928 application number: ANDA072928 Lorazepam LORAZEPAM Golden State Medical Supply, Inc. 32fb5628-bf80-0135-e063-6294a90aa3ab 2025-04-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072928 application number: ANDA072928 Lorazepam LORAZEPAM Teva Pharmaceuticals USA, Inc. 1bf22e97-9425-484d-bac6-519c6bae6a37 2023-06-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072928 application number: ANDA072928
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 70518-3188-0 70518318800 30 TABLET in 1 BLISTER PACK (70518-3188-0) 30 tablet 2021-08-10 0000-00-00 No No Current 70518-3188-1 70518318801 100 POUCH in 1 BOX (70518-3188-1) / 1 TABLET in 1 POUCH (70518-3188-2) 100 pouch 2026-02-02 No No Current 70518-3188-2 70518318802 1 in 1 POUCH Historical 70518-3188-3 70518318803 100 POUCH in 1 BOX (70518-3188-3) / 1 TABLET in 1 POUCH (70518-3188-4) 100 pouch 2026-03-16 No No Current 70518-3188-4 70518318804 1 in 1 POUCH Historical