Lorazepam

Product NDC
71335-1694
11-digit product format
713351694
Labeler code
71335
Product ID
71335-1694_055d96f0-cf01-4766-8627-ee66cd8a291d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203572
Marketing category
ANDA
Marketing start
2017-03-24
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-228072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203572-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203572-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203572-001AB18072bd15b7f6…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ndc (product): 71335-1694
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
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
LORAZEPAMLORAZEPAMA-S Medication Solutions823b1d71-a510-4d34-8015-60b55af23d782023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572

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
11372b3d-52c0-4694-8c88-4b72d3fda9d0Available 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
71335-1694-0Lorazepam10 in 1 BOTTLETABLET109
71335-1694-1Lorazepam30 in 1 BOTTLETABLET309
71335-1694-2Lorazepam120 in 1 BOTTLETABLET1209
71335-1694-3Lorazepam15 in 1 BOTTLETABLET159
71335-1694-4Lorazepam14 in 1 BOTTLETABLET149
71335-1694-5Lorazepam90 in 1 BOTTLETABLET909
71335-1694-6Lorazepam50 in 1 BOTTLETABLET509
71335-1694-7Lorazepam60 in 1 BOTTLETABLET609
71335-1694-8Lorazepam45 in 1 BOTTLETABLET459
71335-1694-9Lorazepam100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1694-1EA - Each71335-1694185972db-16f3-4663-adde-64e014974b4b12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1694LORAZEPAM TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 10 package rows20240828_11372b3d-52c0-4694-8c88-4b72d3fda9d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN11372b3d-52c0-4694-8c88-4b72d3fda9d09
197901lorazepam 1 MG Oral TabletSCD11372b3d-52c0-4694-8c88-4b72d3fda9d09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1694-07133516940010 TABLET in 1 BOTTLE (71335-1694-0) 10 tablet2022-09-260000-00-00NoNoCurrent
71335-1694-17133516940130 TABLET in 1 BOTTLE (71335-1694-1) 30 tablet2021-03-180000-00-00NoNoCurrent
71335-1694-271335169402120 TABLET in 1 BOTTLE (71335-1694-2) 120 tablet2022-09-260000-00-00NoNoCurrent
71335-1694-37133516940315 TABLET in 1 BOTTLE (71335-1694-3) 15 tablet2022-03-210000-00-00NoNoCurrent
71335-1694-47133516940414 TABLET in 1 BOTTLE (71335-1694-4) 14 tablet2022-09-260000-00-00NoNoCurrent
71335-1694-57133516940590 TABLET in 1 BOTTLE (71335-1694-5) 90 tablet2021-01-290000-00-00NoNoCurrent
71335-1694-67133516940650 TABLET in 1 BOTTLE (71335-1694-6) 50 tablet2022-09-260000-00-00NoNoCurrent
71335-1694-77133516940760 TABLET in 1 BOTTLE (71335-1694-7) 60 tablet2021-12-130000-00-00NoNoCurrent
71335-1694-87133516940845 TABLET in 1 BOTTLE (71335-1694-8) 45 tablet2022-09-260000-00-00NoNoCurrent
71335-1694-971335169409100 TABLET in 1 BOTTLE (71335-1694-9) 100 tablet2022-09-260000-00-00NoNoCurrent