FDA.reportPublic FDA data

Lorazepam

Product NDC
69315-904
11-digit product format
693150904
Labeler code
69315
Product ID
69315-904_40249bb6-0d25-4b2f-aa4b-85c15af6bf8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA078203
Marketing category
ANDA
Marketing start
2023-05-16
Substance
LORAZEPAM
Active strength
.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lorazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui197900, 197901, 197902

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-904-01Lorazepam100 in 1 BOTTLETABLET10013
69315-904-05Lorazepam500 in 1 BOTTLETABLET50013
69315-904-10Lorazepam1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-904-01EA - Each69315-90471f41bae-10fa-43dc-b23e-7e80cee4e9c312016-06-14
69315-904-05EA - Each69315-90428f0aff1-066e-4112-aa34-a4530f95397d12016-06-14
69315-904-10EA - Each69315-90474301f7b-12a2-4e27-8edd-44f652d0666d12016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-904LORAZEPAM TABLET [LEADING PHARMA, LLC]13Current NDC, Legacy NDC, 3 package rows20231215_5ca13415-4b77-4131-a9d2-6db26bc49167.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN1009c870-fd98-4e3b-81c8-4184036fb8c216
197900lorazepam 0.5 MG Oral TabletSCD1009c870-fd98-4e3b-81c8-4184036fb8c216
197900LORazepam 0.5 MG Oral TabletPSN5ca13415-4b77-4131-a9d2-6db26bc4916713
197901LORazepam 1 MG Oral TabletPSN5ca13415-4b77-4131-a9d2-6db26bc4916713
197902LORazepam 2 MG Oral TabletPSN5ca13415-4b77-4131-a9d2-6db26bc4916713
197900lorazepam 0.5 MG Oral TabletSCD5ca13415-4b77-4131-a9d2-6db26bc4916713
197901lorazepam 1 MG Oral TabletSCD5ca13415-4b77-4131-a9d2-6db26bc4916713
197902lorazepam 2 MG Oral TabletSCD5ca13415-4b77-4131-a9d2-6db26bc4916713
197900LORazepam 0.5 MG Oral TabletPSNaac672f9-0ba7-4852-b8a7-caac9e4b1e7711
197900LORazepam 0.5 MG Oral TabletPSN62f6eb3b-813d-4890-aca9-799b7fa890df11
197901LORazepam 1 MG Oral TabletPSN62f6eb3b-813d-4890-aca9-799b7fa890df11
197902LORazepam 2 MG Oral TabletPSN62f6eb3b-813d-4890-aca9-799b7fa890df11
197900lorazepam 0.5 MG Oral TabletSCDaac672f9-0ba7-4852-b8a7-caac9e4b1e7711
197900lorazepam 0.5 MG Oral TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197901lorazepam 1 MG Oral TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197902lorazepam 2 MG Oral TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197900LORazepam 0.5 MG Oral TabletPSN4a66b854-4dd6-3746-e054-00144ff8d46c6
197900lorazepam 0.5 MG Oral TabletSCD4a66b854-4dd6-3746-e054-00144ff8d46c6
197900LORazepam 0.5 MG Oral TabletPSN4ab77192-8fe9-2965-e054-00144ff88e885
197900LORazepam 0.5 MG Oral TabletPSNdd704e63-7162-4932-8fd1-473b3b8accca5
197900LORazepam 0.5 MG Oral TabletPSN4832f02d-289c-2fe6-e054-00144ff8d46c5
197900lorazepam 0.5 MG Oral TabletSCD4832f02d-289c-2fe6-e054-00144ff8d46c5
197900lorazepam 0.5 MG Oral TabletSCDdd704e63-7162-4932-8fd1-473b3b8accca5
197900lorazepam 0.5 MG Oral TabletSCD4ab77192-8fe9-2965-e054-00144ff88e885
197900LORazepam 0.5 MG Oral TabletPSNfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197900LORazepam 0.5 MG Oral TabletPSNe563594e-212c-4f31-92ea-294aeab45df34
197900LORazepam 0.5 MG Oral TabletPSN891b2c10-942f-0e4d-e053-2995a90af0284
197900LORazepam 0.5 MG Oral TabletPSNe9052b38-3c9f-4c84-9a0d-98bd99b9ddfd4
197900LORazepam 0.5 MG Oral TabletPSN8e4a2ed9-265c-1be3-e053-2995a90a42504
197901LORazepam 1 MG Oral TabletPSNfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197902LORazepam 2 MG Oral TabletPSNfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197900lorazepam 0.5 MG Oral TabletSCD8e4a2ed9-265c-1be3-e053-2995a90a42504
197900lorazepam 0.5 MG Oral TabletSCDfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197900lorazepam 0.5 MG Oral TabletSCD891b2c10-942f-0e4d-e053-2995a90af0284
197900lorazepam 0.5 MG Oral TabletSCDe563594e-212c-4f31-92ea-294aeab45df34
197900lorazepam 0.5 MG Oral TabletSCDe9052b38-3c9f-4c84-9a0d-98bd99b9ddfd4
197901lorazepam 1 MG Oral TabletSCDfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197902lorazepam 2 MG Oral TabletSCDfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197900LORazepam 0.5 MG Oral TabletPSN91da80c8-3162-43f0-b53e-897070b26a541
197900LORazepam 0.5 MG Oral TabletPSN8cb6b6e8-66ff-46f1-e053-2a95a90a3fd31
197900LORazepam 0.5 MG Oral TabletPSN42b9bc57-cd3a-4ea3-9756-5b5476b301281
197900LORazepam 0.5 MG Oral TabletPSN7bcd505d-4004-4acc-b5f6-7c3fd7eba8551
197900LORazepam 0.5 MG Oral TabletPSN59278102-8ac3-5fd2-e053-2991aa0a5ce21
197900lorazepam 0.5 MG Oral TabletSCD42b9bc57-cd3a-4ea3-9756-5b5476b301281
197900lorazepam 0.5 MG Oral TabletSCD59278102-8ac3-5fd2-e053-2991aa0a5ce21
197900lorazepam 0.5 MG Oral TabletSCD7bcd505d-4004-4acc-b5f6-7c3fd7eba8551
197900lorazepam 0.5 MG Oral TabletSCD8cb6b6e8-66ff-46f1-e053-2a95a90a3fd31
197900lorazepam 0.5 MG Oral TabletSCD91da80c8-3162-43f0-b53e-897070b26a541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-904-0169315090401100 TABLET in 1 BOTTLE (69315-904-01) 100 tablet2023-05-160000-00-00NoNoCurrent
69315-904-0569315090405500 TABLET in 1 BOTTLE (69315-904-05) 500 tablet2023-05-160000-00-00NoNoCurrent
69315-904-10693150904101000 TABLET in 1 BOTTLE (69315-904-10) 1000 tablet2023-05-160000-00-00NoNoCurrent