Lorazepam

Product NDC
60687-820
11-digit product format
606870820
Labeler code
60687
Product ID
60687-820_1f0a358c-b2ef-1088-e063-6394a90add6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203572
Marketing category
ANDA
Marketing start
2025-09-14
Substance
LORAZEPAM
Active strength
.5 mg/1
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 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
A203572-001LORAZEPAMLORAZEPAM0.5MGTABLET / ORALAB2017-12-22
A203572-002LORAZEPAMLORAZEPAM1MGTABLET / ORALAB2017-12-22
A203572-003LORAZEPAMLORAZEPAM2MGTABLET / ORALAB2017-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203572-001AB
A203572-002AB
A203572-003AB

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 06:07:402026-07A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-221e350fbaab3a…

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 06:07:402026-07A203572-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203572-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203572-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203572-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203572-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203572-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203572-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203572-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203572-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203572-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203572-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203572-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203572-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203572-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203572-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203572-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203572-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203572-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203572-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203572-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203572-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203572-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203572-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203572-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Lorazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM.5 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
45e31a87-a8db-4dda-b94b-83535b62e8e2Available 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
60687-820-01Lorazepam100 in 1 CARTONTABLET1001
60687-820-11Lorazepam1 in 1 BLISTER PACKTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-820-01EA - Each60687-820d7025c5c-35c7-4104-9f1c-24bbf76974c812025-11-13
60687-820-11EA - Each60687-8205a34f809-448c-4c2d-8cb3-72091e2d4f4012025-11-13

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 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LORAZEPAMLORAZEPAMPreferred Pharmaceuticals Inc.903351ae-1bb0-4ac0-8430-df24cf2eee762026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LORAZEPAMLORAZEPAMREMEDYREPACK INC.7fa1a011-5e28-4b13-bcd2-5c5fc9b663b22026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LORAZEPAMLORAZEPAMBryant Ranch Prepack46af8e93-3169-408a-b4d8-b8498642801d2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMPreferred Pharmaceuticals Inc.4a50329b-b272-4164-bddf-0d6cea3d7a232026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMBryant Ranch Prepack11372b3d-52c0-4694-8c88-4b72d3fda9d02026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LORAZEPAMLORAZEPAMPD-Rx Pharmaceuticals, Inc.0418ad09-3069-4381-9a8f-e41b234fdac62026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LORAZEPAMLORAZEPAMAurolife Pharma LLC5b851f67-309d-4ef3-8b4b-ade8908256ea2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMAmerican Health Packaging45e31a87-a8db-4dda-b94b-83535b62e8e22025-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 60687-820
LorazepamLORAZEPAMPreferred Pharmaceuticals, Inc.00960fbd-a5da-408b-9867-62982f20906f2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMPreferred Pharmaceuticals, Inc.6cc1f35d-ff33-404e-aa5e-b01eab89863e2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8aaf9bcb-7a4e-ffaa-e053-2995a90a39132025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LORAZEPAMLORAZEPAMDirectRxddcc0b2b-4be2-6d18-e053-2a95a90af9872025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LORAZEPAMLORAZEPAMAdvanced Rx of Tennessee, LLC2a57e549-390b-5482-e063-6394a90aeb3b2024-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8fa33078-c379-41f5-e053-2995a90acced2024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMBryant Ranch Prepack853c762d-0772-4f02-99ca-0bc2911f09f02024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.a4fe8df0-3ce8-b8b8-e053-2995a90a28f42024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8aace309-f3ef-6aef-e053-2995a90aa1972024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.933b5ef3-ec29-1a96-e053-2995a90a2d332024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LORAZEPAMLORAZEPAMA-S Medication Solutions8602cef8-167e-4a8c-b10f-fc3295a3abcc2024-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LORAZEPAMLORAZEPAMAphena Pharma Solutions - Tennessee, LLC247110f2-5468-4593-8d86-41f8c869e03d2023-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN45e31a87-a8db-4dda-b94b-83535b62e8e21
197901LORazepam 1 MG Oral TabletPSN45e31a87-a8db-4dda-b94b-83535b62e8e21
197902LORazepam 2 MG Oral TabletPSN45e31a87-a8db-4dda-b94b-83535b62e8e21
197900lorazepam 0.5 MG Oral TabletSCD45e31a87-a8db-4dda-b94b-83535b62e8e21
197901lorazepam 1 MG Oral TabletSCD45e31a87-a8db-4dda-b94b-83535b62e8e21
197902lorazepam 2 MG Oral TabletSCD45e31a87-a8db-4dda-b94b-83535b62e8e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-820-0160687082001100 BLISTER PACK in 1 CARTON (60687-820-01) / 1 TABLET in 1 BLISTER PACK (60687-820-11) 100 blister pack2025-09-14NoNoCurrent
60687-820-11606870820111 in 1 BLISTER PACKHistorical