Lorazepam

Product NDC
63629-2953
Requested package NDC
63629-2953-3
11-digit product format
636292953
Labeler code
63629
Product ID
63629-2953_09e9b774-8b89-4525-90c6-f10d75050e68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA072926
Marketing category
ANDA
Marketing start
1991-10-31
Marketing end
0000-00-00
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-295363629-2953-3DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2953-1EA - Each63629-2953e903353c-a068-4c75-a8de-857ed2516a9e12013-02-13
63629-2953-2EA - Each63629-295334b36987-a00c-4143-87ba-18df5a97c89612013-02-13
63629-2953-3EA - Each63629-2953215a7e1b-3047-480e-9cda-511e04e3b65c12013-02-13
63629-2953-4EA - Each63629-29533f000ca5-7131-4e7d-8bf2-82c64c64899312013-02-13
63629-2953-5EA - Each63629-2953e123cd89-37f5-448b-98d5-21fca7878e1f12013-02-13
63629-2953-6EA - Each63629-2953688f18f4-8dd7-4136-ab81-4899d7eecf9212013-02-13
63629-2953-8EA - Each63629-2953f9e38167-4237-4e9c-ab88-ff9e729d1d2a12020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [BRYANT RANCH PREPACK]1001
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [BRYANT RANCH PREPACK]1001
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [BRYANT RANCH PREPACK]1001
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2953LORAZEPAM TABLET [BRYANT RANCH PREPACK]1007Legacy NDC20220111_09e9b774-8b89-4525-90c6-f10d75050e68.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
LorazepamLORAZEPAMProficient Rx LPa407d3fe-ff0f-45b0-8a1e-c7a2a11c55692023-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 072926
application number: ANDA072926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2953-36362929530360 TABLET in 1 BOTTLE (63629-2953-3) 60 tablet2007-03-060000-00-00NoNoCurrent