Lorazepam

Product NDC
0093-3425
11-digit product format
000933425
Labeler code
0093
Product ID
0093-3425_979c1de1-fca5-4909-9abf-a568e2a8a3de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA072926
Marketing category
ANDA
Marketing start
2021-10-11
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A072926-001LORAZEPAMLORAZEPAM0.5MGTABLET / 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
A072926-001AB

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 06:07:402026-07A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-313f01610625f2…
2019-09-15 20:21 UTC2019-09A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072926-001LORAZEPAM0.5MGTABLET / ORALAB1991-10-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072926-001LORAZEPAM0.5MGTABLET / 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 06:07:402026-07A072926-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072926-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072926-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072926-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072926-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072926-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072926-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072926-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072926-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072926-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072926-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072926-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072926-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072926-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072926-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072926-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072926-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072926-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072926-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072926-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072926-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072926-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A072926-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072926-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072926-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072926-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A072926-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A072926-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072926-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072926-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072926-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072926-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072926-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072926-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072926-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A072926-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A072926-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072926-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072926-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072926-001AB1e64feba35796…

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
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
0093-3425-01Lorazepam100 in 1 BOTTLE, PLASTICTABLET10012
0093-3425-05Lorazepam500 in 1 BOTTLE, PLASTICTABLET50012
0093-3425-10Lorazepam1000 in 1 BOTTLE, PLASTICTABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3425-01EA - Each0093-3425efcaa2c2-0e9d-4f3d-b2f6-3f162f8264d812022-01-06
0093-3425-05EA - Each0093-342512163650-d233-4d16-ac79-17eff246491912021-12-08
0093-3425-10EA - Each0093-3425af91aee1-9e4b-48bf-a463-caba9baaf9ce12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3425LORAZEPAM 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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMUnit Dose Solutions, Inc.5519bba8-9eb7-a3e0-e063-6294a90afd942026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072926
application number: ANDA072926
LorazepamLORAZEPAMRedpharm Drug5407f327-3a22-8c15-e063-6294a90a31692026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072926
application number: ANDA072926
LorazepamLORAZEPAMREMEDYREPACK INC.ac1f88c2-2cf2-47de-a612-946cd45030902026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072926
application number: ANDA072926
LorazepamLORAZEPAMCoupler LLC51119efa-c1a3-71f0-e063-6394a90a9e2a2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072926
application number: ANDA072926
LorazepamLORAZEPAMPD-Rx Pharmaceuticals, Inc.7999b9c3-6185-4e4e-a4c3-d5d33d6c31d62025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072926
application number: ANDA072926
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC3c20c89f-c8c3-43b3-837e-da413f4497952025-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072926
application number: ANDA072926
LorazepamLORAZEPAMGolden State Medical Supply, Inc.32fb5628-bf80-0135-e063-6294a90aa3ab2025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072926
application number: ANDA072926
LorazepamLORAZEPAMTeva Pharmaceuticals USA, Inc.1bf22e97-9425-484d-bac6-519c6bae6a372023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072926
application number: ANDA072926
ndc (product): 0093-3425
LorazepamLORAZEPAMProficient Rx LPa407d3fe-ff0f-45b0-8a1e-c7a2a11c55692023-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072926
application number: ANDA072926

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN7999b9c3-6185-4e4e-a4c3-d5d33d6c31d615
197900lorazepam 0.5 MG Oral TabletSCD7999b9c3-6185-4e4e-a4c3-d5d33d6c31d615
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
197900LORazepam 0.5 MG Oral TabletPSNac1f88c2-2cf2-47de-a612-946cd45030906
197900lorazepam 0.5 MG Oral TabletSCDac1f88c2-2cf2-47de-a612-946cd45030906
197900LORazepam 0.5 MG Oral TabletPSNa407d3fe-ff0f-45b0-8a1e-c7a2a11c55692
197900LORazepam 0.5 MG Oral TabletPSNf4c415a6-ad4d-78f8-e053-2995a90afa5d2
197900lorazepam 0.5 MG Oral TabletSCDa407d3fe-ff0f-45b0-8a1e-c7a2a11c55692
197900lorazepam 0.5 MG Oral TabletSCDf4c415a6-ad4d-78f8-e053-2995a90afa5d2
197900LORazepam 0.5 MG Oral TabletPSN51119efa-c1a3-71f0-e063-6394a90a9e2a1
197900LORazepam 0.5 MG Oral TabletPSN32fb5628-bf80-0135-e063-6294a90aa3ab1
197900LORazepam 0.5 MG Oral TabletPSNdb4a3ca5-d498-6f75-e053-2995a90a1f941
197900LORazepam 0.5 MG Oral TabletPSNdb63568b-54b5-1abf-e053-2a95a90ac4a71
197901LORazepam 1 MG Oral TabletPSN32fb5628-bf80-0135-e063-6294a90aa3ab1
197902LORazepam 2 MG Oral TabletPSN32fb5628-bf80-0135-e063-6294a90aa3ab1
197900lorazepam 0.5 MG Oral TabletSCD51119efa-c1a3-71f0-e063-6394a90a9e2a1
197900lorazepam 0.5 MG Oral TabletSCD32fb5628-bf80-0135-e063-6294a90aa3ab1
197900lorazepam 0.5 MG Oral TabletSCDdb4a3ca5-d498-6f75-e053-2995a90a1f941
197900lorazepam 0.5 MG Oral TabletSCDdb63568b-54b5-1abf-e053-2a95a90ac4a71
197901lorazepam 1 MG Oral TabletSCD32fb5628-bf80-0135-e063-6294a90aa3ab1
197902lorazepam 2 MG Oral TabletSCD32fb5628-bf80-0135-e063-6294a90aa3ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3425-0100093342501100 TABLET in 1 BOTTLE, PLASTIC (0093-3425-01) 100 tablet2021-12-280000-00-00NoNoCurrent
0093-3425-0500093342505500 TABLET in 1 BOTTLE, PLASTIC (0093-3425-05) 500 tablet2021-11-050000-00-00NoNoCurrent
0093-3425-10000933425101000 TABLET in 1 BOTTLE, PLASTIC (0093-3425-10) 1000 tablet2021-10-110000-00-00NoNoCurrent