Lorazepam

Product NDC
0093-3426
11-digit product format
000933426
Labeler code
0093
Product ID
0093-3426_979c1de1-fca5-4909-9abf-a568e2a8a3de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA072927
Marketing category
ANDA
Marketing start
2021-12-09
Substance
LORAZEPAM
Active strength
1 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072927-001LORAZEPAMLORAZEPAM1MGTABLET / ORALAB1991-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A072927-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-313f01610625f2…
2019-09-15 20:21 UTC2019-09A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072927-001LORAZEPAM1MGTABLET / ORALAB1991-10-31e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A072927-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072927-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072927-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072927-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072927-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072927-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072927-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072927-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072927-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072927-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072927-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072927-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072927-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072927-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072927-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072927-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072927-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072927-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072927-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072927-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072927-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072927-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072927-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072927-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072927-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072927-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072927-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072927-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072927-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072927-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072927-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072927-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072927-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072927-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072927-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072927-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072927-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072927-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072927-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072927-001AB1e64feba35796…

Additional Listing Data#

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

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 · 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
1bf22e97-9425-484d-bac6-519c6bae6a37Available 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
0093-3426-01Lorazepam100 in 1 BOTTLE, PLASTICTABLET10012
0093-3426-05Lorazepam500 in 1 BOTTLE, PLASTICTABLET50012
0093-3426-10Lorazepam1000 in 1 BOTTLE, PLASTICTABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3426-01EA - Each0093-34267a4b3623-8e82-4842-94ff-c50d8e2fc7b512022-01-06
0093-3426-05EA - Each0093-34264b19e124-08c9-4819-9487-dfa60b6c0d5112022-02-07
0093-3426-10EA - Each0093-3426096bdc2f-0614-4d1c-a0ef-e1203131746b12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3426LORAZEPAM TABLET [TEVA PHARMACEUTICALS USA, INC.]12Current NDC, Legacy NDC, 3 package rows20241102_1bf22e97-9425-484d-bac6-519c6bae6a37.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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMREMEDYREPACK INC.6c5356b1-c199-49ad-bb00-fd67c6691f742026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMCoupler LLC54d72943-f8d1-5a78-e063-6294a90a059b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMRedpharm Drug52614947-c96c-3361-e063-6394a90ae1722026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.7afd9a59-3463-4eda-8cf3-ef90be05de3d2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC3c20c89f-c8c3-43b3-837e-da413f4497952025-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMGolden State Medical Supply, Inc.32fb5628-bf80-0135-e063-6294a90aa3ab2025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
LorazepamLORAZEPAMTeva Pharmaceuticals USA, Inc.1bf22e97-9425-484d-bac6-519c6bae6a372023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072927
application number: ANDA072927
ndc (product): 0093-3426

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN7afd9a59-3463-4eda-8cf3-ef90be05de3d16
197901lorazepam 1 MG Oral TabletSCD7afd9a59-3463-4eda-8cf3-ef90be05de3d16
197900LORazepam 0.5 MG Oral TabletPSN1bf22e97-9425-484d-bac6-519c6bae6a3712
197901LORazepam 1 MG Oral TabletPSN1bf22e97-9425-484d-bac6-519c6bae6a3712
197902LORazepam 2 MG Oral TabletPSN1bf22e97-9425-484d-bac6-519c6bae6a3712
197900lorazepam 0.5 MG Oral TabletSCD1bf22e97-9425-484d-bac6-519c6bae6a3712
197901lorazepam 1 MG Oral TabletSCD1bf22e97-9425-484d-bac6-519c6bae6a3712
197902lorazepam 2 MG Oral TabletSCD1bf22e97-9425-484d-bac6-519c6bae6a3712
197900LORazepam 0.5 MG Oral TabletPSN3c20c89f-c8c3-43b3-837e-da413f44979511
197901LORazepam 1 MG Oral TabletPSN3c20c89f-c8c3-43b3-837e-da413f44979511
197902LORazepam 2 MG Oral TabletPSN3c20c89f-c8c3-43b3-837e-da413f44979511
197900lorazepam 0.5 MG Oral TabletSCD3c20c89f-c8c3-43b3-837e-da413f44979511
197901lorazepam 1 MG Oral TabletSCD3c20c89f-c8c3-43b3-837e-da413f44979511
197902lorazepam 2 MG Oral TabletSCD3c20c89f-c8c3-43b3-837e-da413f44979511
197901LORazepam 1 MG Oral TabletPSN6c5356b1-c199-49ad-bb00-fd67c6691f748
197901lorazepam 1 MG Oral TabletSCD6c5356b1-c199-49ad-bb00-fd67c6691f748
197900LORazepam 0.5 MG Oral TabletPSN32fb5628-bf80-0135-e063-6294a90aa3ab1
197901LORazepam 1 MG Oral TabletPSN32fb5628-bf80-0135-e063-6294a90aa3ab1
197901LORazepam 1 MG Oral TabletPSN52614947-c96c-3361-e063-6394a90ae1721
197902LORazepam 2 MG Oral TabletPSN32fb5628-bf80-0135-e063-6294a90aa3ab1
197900lorazepam 0.5 MG Oral TabletSCD32fb5628-bf80-0135-e063-6294a90aa3ab1
197901lorazepam 1 MG Oral TabletSCD32fb5628-bf80-0135-e063-6294a90aa3ab1
197901lorazepam 1 MG Oral TabletSCD52614947-c96c-3361-e063-6394a90ae1721
197902lorazepam 2 MG Oral TabletSCD32fb5628-bf80-0135-e063-6294a90aa3ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3426-0100093342601100 TABLET in 1 BOTTLE, PLASTIC (0093-3426-01) 100 tablet2021-12-090000-00-00NoNoCurrent
0093-3426-0500093342605500 TABLET in 1 BOTTLE, PLASTIC (0093-3426-05) 500 tablet2022-01-110000-00-00NoNoCurrent
0093-3426-10000933426101000 TABLET in 1 BOTTLE, PLASTIC (0093-3426-10) 1000 tablet2021-12-280000-00-00NoNoCurrent