Lorazepam

Product NDC
67544-879
11-digit product format
675440879
Labeler code
67544
Product ID
67544-879_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
1 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 · 13 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67544-879DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-10DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-15DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-20DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-30DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-45DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-53DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-55DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-60DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-70DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-75DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-80DDiscontinued by firm2026-08-17
excluded packagepackage67544-87967544-879-92DDiscontinued 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 4 · 208 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 packagepackage67544-879-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-879-55d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-879-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-879-70d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-879-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-879-75d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-879-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-879-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-879-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-879-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-879-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67544-879-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-55f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-70f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-75f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67544-879-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-552ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-532ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-702ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-752ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-922ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67544-879-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-55a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-92a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67544-879-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-879-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-879-55cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-879-53cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-879-70cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-879-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-879-75cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67544-879-15cfe11265f3b6…090c488252e2…

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
67544-879-10EA - Each67544-879caa339d8-faf2-4ca1-b5ab-7ce59af6658612014-09-03
67544-879-15EA - Each67544-879c68879f0-04da-4f92-bac8-70a5e9361e3c12014-05-02
67544-879-20EA - Each67544-879f3732036-e7e2-4365-b6c5-ad51eb7ebd2912014-07-02
67544-879-30EA - Each67544-879f1cbe6c8-6ba1-4b7d-98c3-7a7a363e16d312014-05-02
67544-879-45EA - Each67544-879d731b733-7ab1-4435-8e5f-6084bcc5dd6012014-05-02
67544-879-53EA - Each67544-87933d28e02-8690-4cf1-83c1-975b860af4f612014-05-02
67544-879-55EA - Each67544-87908819ae6-8cc1-4b0f-ace5-3076d2b1f5ec12014-09-03
67544-879-60EA - Each67544-879ac3228b2-df01-4b87-a827-31d2cd09f85a12014-05-02
67544-879-70EA - Each67544-8794cf424c7-c07e-4566-997d-8027fec2156912014-05-02
67544-879-75EA - Each67544-879ae1781ac-c4ea-461b-9fcf-ee5c73822d9d12014-05-02
67544-879-80EA - Each67544-879d9136285-c077-4867-83ec-561cde9f5c6412014-05-02
67544-879-92EA - Each67544-879ba1d5be5-17aa-4aad-b664-01a4db84287612014-09-03

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