FDA.reportPublic FDA data

Lorazepam

Product NDC
0904-6007
11-digit product format
009046007
Labeler code
0904
Product ID
0904-6007_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
.5 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
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
0904-6007-60Lorazepam100 in 1 BOTTLETABLET10011
0904-6007-61Lorazepam100 in 1 CARTONTABLET10011
0904-6007-61Lorazepam1 in 1 BLISTER PACKTABLET111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6007-40EA - Each0904-60075d2adda5-a9f8-4945-a6ed-a1ec637f032d12012-07-24
0904-6007-60EA - Each0904-6007d95213b6-761c-462c-b6f3-8719c9149c5e12012-07-24
0904-6007-61EA - Each0904-6007932a126c-c007-47b4-966b-63ae82cf578212016-07-19

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
0904-6007LORAZEPAM 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
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
197900LORazepam 0.5 MG Oral TabletPSNe83ae439-3fa5-453f-9073-4bf8c797df473
197900lorazepam 0.5 MG Oral TabletSCDe83ae439-3fa5-453f-9073-4bf8c797df473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6007-6000904600760100 TABLET in 1 BOTTLE (0904-6007-60) 100 tablet2009-10-090000-00-00NoNoCurrent
0904-6007-6100904600761100 BLISTER PACK in 1 CARTON (0904-6007-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2009-10-092026-08-31NoNoCurrent