Home NDC 76329-8261 Lorazepam
Product NDC 76329-8261
11-digit product format 763298261
Labeler code 76329
Product ID 76329-8261_b85a6695-55b9-4780-a803-33f8f2464138
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lorazepam
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler International Medication Systems, Limited
Application ANDA076150
Marketing category ANDA
Marketing start 2012-12-01
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 1 .
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 A076150-001 LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076150-001 AP
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076150-001 LORAZEPAM 2MG/ML INJECTABLE / INJECTION AP 2004-11-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 238100 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 76329-8261-1 Lorazepam 10 mL in 1 VIAL INJECTION 10 13 76329-8261-1 Lorazepam 10 in 1 CARTON INJECTION 10 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76329-8261 LORAZEPAM INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ] 13 Current NDC, Legacy NDC, 2 package rows 20240306_7dda070d-7809-46c4-8592-eb4e4c509707.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 International Medication Systems, Limited 7dda070d-7809-46c4-8592-eb4e4c509707 2024-03-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076150 application number: ANDA076150 ndc (product): 76329-8261
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 76329-8261-1 76329826101 10 VIAL in 1 CARTON (76329-8261-1) / 10 mL in 1 VIAL 10 vial 2012-12-01 0000-00-00 No No Current