Home NDC 17856-3532-1 Lorazepam
Product NDC 17856-3532
Requested package NDC 17856-3532-1
11-digit product format 178563532
Labeler code 17856
Product ID 17856-3532_0eda2785-681b-4179-b385-cd02db3ae61f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lorazepam
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA072755
Marketing category ANDA
Marketing start 2019-04-05
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 2022-12-31
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 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A072755-001 LORAZEPAM INTENSOL LORAZEPAM 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072755-001 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 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072755-001 LORAZEPAM INTENSOL 2MG/ML CONCENTRATE / ORAL AA RS 1991-06-28 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 17856-3532-1 Lorazepam 0.125 mL in 1 SYRINGE SOLUTION, CONCENTRATE 0.125 3 17856-3532-1 Lorazepam 60 in 1 BOX, UNIT-DOSE SOLUTION, CONCENTRATE 60 3 17856-3532-2 Lorazepam 0.25 mL in 1 SYRINGE SOLUTION, CONCENTRATE 0.25 3 17856-3532-2 Lorazepam 60 in 1 BOX, UNIT-DOSE SOLUTION, CONCENTRATE 60 3 17856-3532-3 Lorazepam 120 in 1 BOX, UNIT-DOSE SOLUTION, CONCENTRATE 120 3 17856-3532-3 Lorazepam 0.5 mL in 1 SYRINGE SOLUTION, CONCENTRATE 0.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-3532 LORAZEPAM SOLUTION, CONCENTRATE [ATLANTIC BIOLOGICALS CORP.] 3 Legacy NDC, 6 package rows 20210121_908855b7-a356-428b-8a2b-ac52dc5726f2.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 Hikma Pharmaceuticals USA Inc. 5ff82103-cc57-4af9-9362-82a7c686271d 2021-03-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072755 application number: ANDA072755
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 17856-3532-1 17856353201 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-3532-1) > .125 mL in 1 SYRINGE 60 syringe 2021-01-20 0000-00-00 No No Current