Lorazepam

Product NDC
0904-6008
11-digit product format
009046008
Labeler code
0904
Product ID
0904-6008_6b6c2fbc-d12d-41d7-b49d-cf374c773cbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078203
Marketing category
ANDA
Marketing start
2009-10-09
Marketing end
2026-08-31
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lorazepam

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM1 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
0904-6008-60Lorazepam100 in 1 BOTTLETABLET10011
0904-6008-61Lorazepam1 in 1 BLISTER PACKTABLET111
0904-6008-61Lorazepam100 in 1 CARTONTABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6008-60EA - Each0904-6008afa73630-6d68-4aa2-bd59-82c0e4587a8e12012-07-24
0904-6008-61EA - Each0904-6008bcdbf7e8-f997-48ce-aae5-de9a5b6f00f212016-07-19

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
0904-6008LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]11Current NDC, Legacy NDC, 3 package rows20250122_62f6eb3b-813d-4890-aca9-799b7fa890df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN7b243fa7-6408-898b-e053-2991aa0a7acf12
197901lorazepam 1 MG Oral TabletSCD7b243fa7-6408-898b-e053-2991aa0a7acf12
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 TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197901lorazepam 1 MG Oral TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197902lorazepam 2 MG Oral TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197901LORazepam 1 MG Oral TabletPSNeb068a0f-5c0e-4218-b4c5-a0d0b1d362bd9
197901lorazepam 1 MG Oral TabletSCDeb068a0f-5c0e-4218-b4c5-a0d0b1d362bd9
197901LORazepam 1 MG Oral TabletPSN8df3eed3-c936-4772-ab08-574c54dd8bf52
197901LORazepam 1 MG Oral TabletPSNf4c3c2c5-52ce-a168-e053-2995a90affb42
197901lorazepam 1 MG Oral TabletSCD8df3eed3-c936-4772-ab08-574c54dd8bf52
197901lorazepam 1 MG Oral TabletSCDf4c3c2c5-52ce-a168-e053-2995a90affb42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6008-6000904600860100 TABLET in 1 BOTTLE (0904-6008-60) 100 tablet2009-10-092026-08-31NoNoCurrent
0904-6008-6100904600861100 BLISTER PACK in 1 CARTON (0904-6008-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2009-10-092026-08-31NoNoCurrent