Lorazepam

Product NDC
70518-0486
11-digit product format
705180486
Labeler code
70518
Product ID
70518-0486_47f7585d-a4c8-d83a-e063-6394a90ab77b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078203
Marketing category
ANDA
Marketing start
2017-05-08
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

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-0486-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-0486-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-0486-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-0486-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-0486-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-0486-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-0486-00efc9e666f02…f202fb6c5f17…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Lorazepam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O26FZP769LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197901Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0a33933-f697-4d3b-ba99-8a995a4b6c6bAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0486-0Lorazepam30 in 1 BLISTER PACKTABLET3013

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
ndc (product): 70518-0486
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
197901LORazepam 1 MG Oral TabletPSNa0a33933-f697-4d3b-ba99-8a995a4b6c6b13
197901lorazepam 1 MG Oral TabletSCDa0a33933-f697-4d3b-ba99-8a995a4b6c6b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0486-07051804860030 TABLET in 1 BLISTER PACK (70518-0486-0) 30 tablet2017-05-080000-00-00NoNoCurrent