Lorazepam

Product NDC
0904-6008
11-digit product format
009046008
Labeler code
0904
Product ID
0904-6008_6b6c2fbc-d12d-41d7-b49d-cf374c773cbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078203
Marketing category
ANDA
Marketing start
2009-10-09
Marketing end
2026-08-31
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

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

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197900Internal RxNorm lookup
197901Internal RxNorm lookup
197902Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
62f6eb3b-813d-4890-aca9-799b7fa890dfAvailable 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
0904-6008-60Lorazepam100 in 1 BOTTLETABLET10011
0904-6008-61Lorazepam1 in 1 BLISTER PACKTABLET111
0904-6008-61Lorazepam100 in 1 CARTONTABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6008-60EA - Each0904-6008afa73630-6d68-4aa2-bd59-82c0e4587a8e12012-07-24
0904-6008-61EA - Each0904-6008bcdbf7e8-f997-48ce-aae5-de9a5b6f00f212016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6008LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]11Current NDC, Legacy NDC, 3 package rows20250122_62f6eb3b-813d-4890-aca9-799b7fa890df.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
ndc (product): 0904-6008
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 TabletPSN7b243fa7-6408-898b-e053-2991aa0a7acf12
197901lorazepam 1 MG Oral TabletSCD7b243fa7-6408-898b-e053-2991aa0a7acf12
197900LORazepam 0.5 MG Oral TabletPSN62f6eb3b-813d-4890-aca9-799b7fa890df11
197901LORazepam 1 MG Oral TabletPSN62f6eb3b-813d-4890-aca9-799b7fa890df11
197902LORazepam 2 MG Oral TabletPSN62f6eb3b-813d-4890-aca9-799b7fa890df11
197900lorazepam 0.5 MG Oral TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197901lorazepam 1 MG Oral TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197902lorazepam 2 MG Oral TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197901LORazepam 1 MG Oral TabletPSNeb068a0f-5c0e-4218-b4c5-a0d0b1d362bd9
197901lorazepam 1 MG Oral TabletSCDeb068a0f-5c0e-4218-b4c5-a0d0b1d362bd9
197901LORazepam 1 MG Oral TabletPSN8df3eed3-c936-4772-ab08-574c54dd8bf52
197901LORazepam 1 MG Oral TabletPSNf4c3c2c5-52ce-a168-e053-2995a90affb42
197901lorazepam 1 MG Oral TabletSCD8df3eed3-c936-4772-ab08-574c54dd8bf52
197901lorazepam 1 MG Oral TabletSCDf4c3c2c5-52ce-a168-e053-2995a90affb42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6008-6000904600860100 TABLET in 1 BOTTLE (0904-6008-60) 100 tablet2009-10-092026-08-31NoNoCurrent
0904-6008-6100904600861100 BLISTER PACK in 1 CARTON (0904-6008-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2009-10-092026-08-31NoNoCurrent