Lorazepam

Product NDC
67544-982
11-digit product format
675440982
Labeler code
67544
Product ID
67544-982_dc10ad3e-db44-4346-8945-fe25b0999f9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077657
Marketing category
ANDA
Marketing start
2013-03-05
Marketing end
0000-00-00
Substance
LORAZEPAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67544-982DDiscontinued by firm2026-08-17
excluded packagepackage67544-98267544-982-15DDiscontinued by firm2026-08-17
excluded packagepackage67544-98267544-982-30DDiscontinued by firm2026-08-17
excluded packagepackage67544-98267544-982-45DDiscontinued by firm2026-08-17
excluded packagepackage67544-98267544-982-53DDiscontinued by firm2026-08-17
excluded packagepackage67544-98267544-982-60DDiscontinued by firm2026-08-17
excluded packagepackage67544-98267544-982-70DDiscontinued by firm2026-08-17
excluded packagepackage67544-98267544-982-75DDiscontinued by firm2026-08-17
excluded packagepackage67544-98267544-982-80DDiscontinued by firm2026-08-17
excluded packagepackage67544-98267544-982-90DDiscontinued by firm2026-08-17
excluded packagepackage67544-98267544-982-92DDiscontinued 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 3 · 176 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 packagepackage67544-982-75d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-982-70d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-982-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-982-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-982-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-982-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-982-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-982-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-982-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-982-53d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-982-75f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-982-70f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-982-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-982-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-982-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-982-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-982-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-982-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-982-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-982-53f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-982-752ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-982-702ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-982-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-982-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-982-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-982-922ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-982-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-982-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-982-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-982-532ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-982-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-982-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-982-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-982-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-982-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-982-92a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-982-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-982-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-982-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-982-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-982-75cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-982-70cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-982-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-982-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-982-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-982-92cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-982-80cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-982-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-982-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-982-53cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-982-75cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-982-70cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-982-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67544-982-60cdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077657-001LORAZEPAMLORAZEPAM0.5MGTABLET / ORAL2006-03-16
A077657-002LORAZEPAMLORAZEPAM1MGTABLET / ORAL2006-03-16
A077657-003LORAZEPAMLORAZEPAM2MGTABLET / ORAL2006-03-16

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-16caaa826d4ba7…
2026-08-18 06:07:402026-07A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077657-002LORAZEPAM1MGTABLET / ORAL2006-03-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077657-003LORAZEPAM2MGTABLET / ORAL2006-03-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077657-001LORAZEPAM0.5MGTABLET / ORAL2006-03-161e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077657-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077657-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077657-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077657-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077657-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077657-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077657-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077657-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077657-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077657-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077657-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077657-003AB1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-982-15EA - Each67544-9822572ab41-92ca-4601-9ddd-7bbe45d71f5c12014-05-02
67544-982-30EA - Each67544-982a11cce0e-e4aa-4850-b402-aa3db9ab541c12014-05-02
67544-982-45EA - Each67544-982f52d155b-3c24-449e-889c-c189ffa21ffa12014-05-02
67544-982-53EA - Each67544-982f39d6020-4a2d-4293-85c9-0145414c1c3d12014-05-02
67544-982-60EA - Each67544-98228e67c6e-16f3-4463-ac79-7cd70b21542512014-05-02
67544-982-70EA - Each67544-9824c797d91-7f4c-4d86-9a2d-8bb1cbbb5e3112014-05-02
67544-982-75EA - Each67544-98234627f56-cbc8-48ab-916b-f1b8b7ba75b712014-05-02
67544-982-80EA - Each67544-98256d16aad-6022-48dc-a6bd-47965305f7e712014-05-02
67544-982-92EA - Each67544-98249d62b36-b126-47c7-8d03-f56903963b4d12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UILORAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2