Lorazepam

Product NDC
53002-7721
Requested package NDC
53002-7721-2
11-digit product format
530027721
Labeler code
53002
Product ID
53002-7721_d6a3eb06-5274-46f0-a4c0-8fa76ac73c47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078203
Marketing category
ANDA
Marketing start
2007-10-01
Marketing end
0000-00-00
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-772153002-7721-2IInactivated by FDA2026-08-17

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078203-001LORAZEPAMLORAZEPAM0.5MGTABLET / ORALAB2007-07-30
A078203-002LORAZEPAMLORAZEPAM1MGTABLET / ORALAB2007-07-30
A078203-003LORAZEPAMLORAZEPAM2MGTABLET / ORALAB2007-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078203-001AB
A078203-002AB
A078203-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-30caaa826d4ba7…
2026-08-18 06:07:402026-07A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078203-002LORAZEPAM1MGTABLET / ORALAB2007-07-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078203-003LORAZEPAM2MGTABLET / ORALAB2007-07-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078203-001LORAZEPAM0.5MGTABLET / ORALAB2007-07-301e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078203-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078203-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078203-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078203-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078203-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078203-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078203-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078203-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078203-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078203-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078203-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078203-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078203-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078203-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078203-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078203-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078203-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078203-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078203-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078203-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078203-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078203-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078203-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078203-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078203-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078203-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078203-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078203-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078203-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078203-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078203-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078203-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078203-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078203-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078203-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078203-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078203-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078203-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078203-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078203-001AB11e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a759f740-8682-4896-9194-8b6c103c9aeeProduct name320250716
b7badb1c-6d3f-4f95-a4ca-ce69992e58a1Product name120220308
5d98a0ba-a64b-d9b2-e6ec-87edbb57a285Product name220180320
ac8efea8-f412-295f-00ce-b095e5cbc115Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-7721-1Lorazepam10 in 1 BOTTLETABLET105
53002-7721-2Lorazepam20 in 1 BOTTLETABLET205
53002-7721-3Lorazepam30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-7721LORAZEPAM TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 3 package rows20201224_dd704e63-7162-4932-8fd1-473b3b8accca.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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMREMEDYREPACK INC.be9f8bda-1cd9-40a6-a4da-b5961389fb5b2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMREMEDYREPACK INC.eb068a0f-5c0e-4218-b4c5-a0d0b1d362bd2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMREMEDYREPACK INC.d6364be4-056b-4ebe-83bc-3fc85e8f488c2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMREMEDYREPACK INC.b707ecb2-644c-4323-ab0e-7bc5929cd5602026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMREMEDYREPACK INC.0cd02e52-ead5-4b2a-9708-c7c4be7b79952026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMCoupler LLC5114810c-025f-6113-e063-6294a90af5382026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMREMEDYREPACK INC.1009c870-fd98-4e3b-81c8-4184036fb8c22026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMA-S Medication Solutions8361519b-be1a-4542-a782-d7cdfa153e862026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMREMEDYREPACK INC.a0a33933-f697-4d3b-ba99-8a995a4b6c6b2026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LORAZEPAMLORAZEPAMDIRECT RX4832f02d-289c-2fe6-e054-00144ff8d46c2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMRedPharm Drug, Inc.891b2c10-942f-0e4d-e053-2995a90af0282025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMPharmPak, Inc.b6e4d2c7-10c0-4d77-be7b-caa3d3b869972025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.0681c8db-ff09-4258-a5e0-76a26b0ea0af2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMMajor Pharmaceuticals62f6eb3b-813d-4890-aca9-799b7fa890df2025-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.4a66b854-4dd6-3746-e054-00144ff8d46c2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.503834f9-fa2e-5e23-e054-00144ff88e882024-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMA-S Medication Solutionsbe85b116-9f09-403a-8e0d-e77e344d3a9a2024-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.4a66b854-4dc1-3746-e054-00144ff8d46c2024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.4ab77192-8fe9-2965-e054-00144ff88e882024-07-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203
LorazepamLORAZEPAMNuCare Pharmaceuticals, Inc.50379c41-2676-590c-e054-00144ff8d46c2024-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078203
application number: ANDA078203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSNdd704e63-7162-4932-8fd1-473b3b8accca5
197900lorazepam 0.5 MG Oral TabletSCDdd704e63-7162-4932-8fd1-473b3b8accca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-7721-25300277210220 TABLET in 1 BOTTLE (53002-7721-2) 20 tablet2019-01-010000-00-00NoNoCurrent