Lorazepam

Product NDC
71610-600
11-digit product format
716100600
Labeler code
71610
Product ID
71610-600_c21d4b84-cd42-458a-a695-a9d237afaaa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203572
Marketing category
ANDA
Marketing start
2017-03-24
Substance
LORAZEPAM
Active strength
2 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 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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM2 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
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
1c956cc1-9217-46e0-80a3-7c811163d3f1Available 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
71610-600-30Lorazepam30 in 1 BOTTLETABLET301
71610-600-53Lorazepam60 in 1 BOTTLETABLET601
71610-600-60Lorazepam90 in 1 BOTTLETABLET901
71610-600-70Lorazepam120 in 1 BOTTLETABLET1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-600-30EA - Each71610-60022ebe92f-88ba-4c4a-b087-c28e9f98a92312021-11-09
71610-600-53EA - Each71610-6001e609b30-8be2-4d6e-ab0f-26ff7e1936d612021-11-09
71610-600-60EA - Each71610-6008de164e9-f801-4565-8fc7-54de5ee51d2012021-11-09
71610-600-70EA - Each71610-60035598bac-9027-4136-bb0c-e3b108e4e1bd12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-600LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 4 package rows20211005_1c956cc1-9217-46e0-80a3-7c811163d3f1.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 · 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197902LORazepam 2 MG Oral TabletPSN1c956cc1-9217-46e0-80a3-7c811163d3f11
197902lorazepam 2 MG Oral TabletSCD1c956cc1-9217-46e0-80a3-7c811163d3f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-600-307161006003030 TABLET in 1 BOTTLE (71610-600-30) 30 tablet2021-09-290000-00-00NoNoCurrent
71610-600-537161006005360 TABLET in 1 BOTTLE (71610-600-53) 60 tablet2021-09-210000-00-00NoNoCurrent
71610-600-607161006006090 TABLET in 1 BOTTLE (71610-600-60) 90 tablet2021-09-210000-00-00NoNoCurrent
71610-600-7071610060070120 TABLET in 1 BOTTLE (71610-600-70) 120 tablet2021-09-210000-00-00NoNoCurrent