Lorazepam

Product NDC
0603-4246
11-digit product format
006034246
Labeler code
0603
Product ID
0603-4246_bf42e19a-d10c-42dc-a102-7b3eab2f330e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Qualitest Pharmaceuticals
Application
ANDA077754
Marketing category
ANDA
Marketing start
2006-05-10
Marketing end
2020-05-30
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 productproduct0603-4246DDiscontinued by firm2026-09-14
excluded packagepackage0603-42460603-4246-21DDiscontinued by firm2026-09-14
excluded packagepackage0603-42460603-4246-28DDiscontinued by firm2026-09-14
excluded packagepackage0603-42460603-4246-32DDiscontinued by firm2026-09-14

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-4246-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-4246-32d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-4246-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-4246-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-4246-32f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-4246-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-4246-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-4246-322ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-4246-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-4246-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-4246-32a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-4246-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-4246-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-4246-32cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-4246-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-4246-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-4246-32cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-4246-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-4246-28302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-4246-32302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-4246-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-4246-28ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-4246-32ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-4246-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-4246-280efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-4246-320efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-4246-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-4246-28ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-4246-32ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-4246-21ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-4246-28367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-4246-32367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-4246-21367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-4246-28557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-4246-32557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-4246-21557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077754-001LORAZEPAMLORAZEPAM0.5MGTABLET / ORALAB2006-05-10
A077754-002LORAZEPAMLORAZEPAM1MGTABLET / ORALAB2006-05-10
A077754-003LORAZEPAMLORAZEPAM2MGTABLET / ORALAB2006-05-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077754-001AB
A077754-002AB
A077754-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-1084e616aacf4f…
2026-09-14 22:38:342026-08A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-1084e616aacf4f…
2026-09-14 22:38:342026-08A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-1084e616aacf4f…
2026-08-18 06:07:402026-07A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-10301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077754-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077754-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077754-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077754-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077754-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077754-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077754-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077754-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077754-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077754-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077754-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077754-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077754-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077754-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077754-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077754-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077754-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077754-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077754-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077754-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077754-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077754-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077754-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077754-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077754-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077754-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077754-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077754-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077754-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077754-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077754-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077754-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077754-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077754-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077754-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077754-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077754-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077754-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077754-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077754-001AB1301d65b070ca…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-4246-21EA - Each0603-424625fa03c3-1c00-4e22-8295-29fbd6f1d17712013-12-02
0603-4246-28EA - Each0603-4246f628ad19-cf89-402f-a225-43db9fbdd9d712013-12-02
0603-4246-32EA - Each0603-4246c78bf0a4-efc0-48af-bf4d-d7774a71ae6b12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]6
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LORAZEPAM TABLET LORAZEPAM TABLET [QUALITEST PHARMACEUTICALS]6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN4e409ad8-0090-1fe1-e054-00144ff8d46c3
197900lorazepam 0.5 MG Oral TabletSCD4e409ad8-0090-1fe1-e054-00144ff8d46c3