Lorazepam

Product NDC
0591-0240
11-digit product format
005910240
Labeler code
0591
Product ID
0591-0240_a2062d88-3cf7-4da0-9cf5-d1fa5079100d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA072926
Marketing category
ANDA
Marketing start
1991-10-31
Marketing end
2023-04-30
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0591-0240DDiscontinued by firm2026-08-17
excluded packagepackage0591-02400591-0240-01DDiscontinued by firm2026-08-17
excluded packagepackage0591-02400591-0240-05DDiscontinued by firm2026-08-17
excluded packagepackage0591-02400591-0240-10DDiscontinued 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 2 · 62 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0591-0240-10DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0591-0240-05DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0591-0240-01DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage0591-0240-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage0591-0240-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip6db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage0591-0240-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage0591-0240-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage0591-0240-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip4bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage0591-0240-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…

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…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0591-0240-012020-07-22C16284748780-1ab0e2407-26c3-f274-e053-dbdaa90a6471Lorazepam Tablets, USP C-IV
0591-0240-052020-07-22C16284748780-1ab0e2407-26c3-f274-e053-dbdaa90a6471Lorazepam Tablets, USP C-IV
0591-0240-102020-07-22C16284748780-1ab0e2407-26c3-f274-e053-dbdaa90a6471Lorazepam Tablets, USP C-IV

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0240-01EA - Each0591-0240423e8bde-9fe7-46e1-a672-9e15b05fb3e712012-07-24
0591-0240-05EA - Each0591-0240f3bb260d-4f86-411d-ba96-9b710ecb4f3012012-07-24
0591-0240-10EA - Each0591-02404f14b744-c04f-4530-86bc-ff5eb28ad5c012012-07-24

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
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [ACTAVIS PHARMA, INC.]8
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [ACTAVIS PHARMA, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [ACTAVIS PHARMA, INC.]8
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [ACTAVIS PHARMA, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [ACTAVIS PHARMA, INC.]8
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [ACTAVIS PHARMA, INC.]8
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM (LORAZEPAM) TABLET [PD-RX PHARMACEUTICALS, INC.]6
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM (LORAZEPAM) TABLET [PD-RX PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM (LORAZEPAM) TABLET [PD-RX PHARMACEUTICALS, INC.]6
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM (LORAZEPAM) TABLET [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM (LORAZEPAM) TABLET [PD-RX PHARMACEUTICALS, INC.]6
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM (LORAZEPAM) TABLET [PD-RX PHARMACEUTICALS, INC.]6
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]5
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [STAT RX USA LLC]4
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [STAT RX USA LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [STAT RX USA LLC]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [STAT RX USA LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [STAT RX USA LLC]4
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [STAT RX USA LLC]4
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN84e74f60-4e4f-412f-a3ff-f3252838f3714
197901LORazepam 1 MG Oral TabletPSN84e74f60-4e4f-412f-a3ff-f3252838f3714
197900lorazepam 0.5 MG Oral TabletSCD84e74f60-4e4f-412f-a3ff-f3252838f3714
197901lorazepam 1 MG Oral TabletSCD84e74f60-4e4f-412f-a3ff-f3252838f3714
197900LORazepam 0.5 MG Oral TabletPSN0007892c-8c17-400d-b820-020aa32f433b3
197901LORazepam 1 MG Oral TabletPSN0007892c-8c17-400d-b820-020aa32f433b3
197902LORazepam 2 MG Oral TabletPSN0007892c-8c17-400d-b820-020aa32f433b3
197900lorazepam 0.5 MG Oral TabletSCD0007892c-8c17-400d-b820-020aa32f433b3
197901lorazepam 1 MG Oral TabletSCD0007892c-8c17-400d-b820-020aa32f433b3
197902lorazepam 2 MG Oral TabletSCD0007892c-8c17-400d-b820-020aa32f433b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-0240-0100591024001100 TABLET in 1 BOTTLE, PLASTIC (0591-0240-01) 100 tablet1991-10-312023-04-30NoNoCurrent
0591-0240-0500591024005500 TABLET in 1 BOTTLE, PLASTIC (0591-0240-05) 500 tablet1991-10-312023-04-30NoNoCurrent
0591-0240-10005910240101000 TABLET in 1 BOTTLE, PLASTIC (0591-0240-10) 1000 tablet1991-10-312023-04-30NoNoCurrent