FDA.reportPublic FDA data

Lorazepam

Product NDC
0641-6046
11-digit product format
006416046
Labeler code
0641
Product ID
0641-6046_7c73dbc6-2623-4443-9b05-97dec7a0be2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA018140
Marketing category
NDA
Marketing start
1980-07-25
Substance
LORAZEPAM
Active strength
2 mg/mL
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
LORAZEPAM2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui238100, 238101, 1665188, 1665326

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
0641-6046-01Lorazepam10 mL in 1 VIALINJECTION1010
0641-6046-10Lorazepam10 in 1 CARTONINJECTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6046-01ML - Milliliter0641-60462d5b77fd-30db-4035-a81a-1e8998e10dfe12012-07-24
0641-6046-10ML - Milliliter0641-6046183a7eeb-e3b8-4a8c-a8d2-7d958535d09f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LORAZEPAM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6046LORAZEPAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20240410_e9b54e42-04cf-4c62-90e1-36f7b31a4e81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665188LORazepam 2 MG in 1 ML InjectionPSNe9b54e42-04cf-4c62-90e1-36f7b31a4e8110
238100LORazepam 2 MG/ML Injectable SolutionPSNe9b54e42-04cf-4c62-90e1-36f7b31a4e8110
1665326LORazepam 4 MG in 1 ML InjectionPSNe9b54e42-04cf-4c62-90e1-36f7b31a4e8110
238101LORazepam 4 MG/ML Injectable SolutionPSNe9b54e42-04cf-4c62-90e1-36f7b31a4e8110
16651881 ML lorazepam 2 MG/ML InjectionSCDe9b54e42-04cf-4c62-90e1-36f7b31a4e8110
16653261 ML lorazepam 4 MG/ML InjectionSCDe9b54e42-04cf-4c62-90e1-36f7b31a4e8110
238100lorazepam 2 MG/ML Injectable SolutionSCDe9b54e42-04cf-4c62-90e1-36f7b31a4e8110
238101lorazepam 4 MG/ML Injectable SolutionSCDe9b54e42-04cf-4c62-90e1-36f7b31a4e8110
1665188lorazepam 2 MG per 1 ML InjectionSYe9b54e42-04cf-4c62-90e1-36f7b31a4e8110
1665326lorazepam 4 MG per 1 ML InjectionSYe9b54e42-04cf-4c62-90e1-36f7b31a4e8110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6046-010064160460110 mL in 1 VIAL10 mlHistorical
0641-6046-100064160461010 VIAL in 1 CARTON (0641-6046-10) / 10 mL in 1 VIAL (0641-6046-01) 10 vial1980-07-250000-00-00NoNoCurrent