Home NDC 72789-226 Lorazepam
Product NDC 72789-226
11-digit product format 727890226
Labeler code 72789
Product ID 72789-226_5ec352bc-1b45-10a8-e063-6294a90a33cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lorazepam
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA072927
Marketing category ANDA
Marketing start 2021-12-09
Substance LORAZEPAM
Active strength 1 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 A072927-001 LORAZEPAM LORAZEPAM 1MG 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 A072927-001 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 · 45 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 2026-11-14 07:37:17 2026-10 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072927-001 LORAZEPAM 1MG TABLET / ORAL AB 1991-10-31 3bdfa0b2c4d7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 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 2027-12-31 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 72789-226-04 Lorazepam 4 in 1 BOTTLE, PLASTIC TABLET 4 16 72789-226-06 Lorazepam 6 in 1 BOTTLE, PLASTIC TABLET 6 16 72789-226-15 Lorazepam 15 in 1 BOTTLE, PLASTIC TABLET 15 16 72789-226-30 Lorazepam 30 in 1 BOTTLE, PLASTIC TABLET 30 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-226 LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.] 15 Current NDC, Legacy NDC, 4 package rows 20241011_7afd9a59-3463-4eda-8cf3-ef90be05de3d.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lorazepam LORAZEPAM REMEDYREPACK INC. 6c5356b1-c199-49ad-bb00-fd67c6691f74 2026-08-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072927 application number: ANDA072927 Lorazepam LORAZEPAM Coupler LLC 54d72943-f8d1-5a78-e063-6294a90a059b 2026-06-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072927 application number: ANDA072927 Lorazepam LORAZEPAM Redpharm Drug 52614947-c96c-3361-e063-6394a90ae172 2026-05-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072927 application number: ANDA072927 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): 072927 application number: ANDA072927 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): 072927 application number: ANDA072927
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 72789-226-04 72789022604 4 TABLET in 1 BOTTLE, PLASTIC (72789-226-04) 4 tablet 2022-02-04 0000-00-00 No No Current 72789-226-06 72789022606 6 TABLET in 1 BOTTLE, PLASTIC (72789-226-06) 6 tablet 2022-02-04 0000-00-00 No No Current 72789-226-15 72789022615 15 TABLET in 1 BOTTLE, PLASTIC (72789-226-15) 15 tablet 2022-02-04 0000-00-00 No No Current 72789-226-30 72789022630 30 TABLET in 1 BOTTLE, PLASTIC (72789-226-30) 30 tablet 2022-01-28 0000-00-00 No No Current