FDA.reportPublic FDA data

Lorazepam

Product NDC
0641-6207
11-digit product format
006416207
Labeler code
0641
Product ID
0641-6207_4f2988b1-2854-4051-962f-07cc925608ab
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

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
0641-6207-01Lorazepam1 mL in 1 VIALINJECTION14
0641-6207-25Lorazepam25 in 1 CARTONINJECTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6207-01ML - Milliliter0641-6207bae05ac9-ffc5-4459-a3da-fa82475ca75312018-01-12
0641-6207-25ML - Milliliter0641-62073284cc80-dd3b-4918-8594-fffbc9398e3312018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6207LORAZEPAM INJECTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20220427_b79b38ee-c29d-4099-964f-000031f47f5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238100LORazepam 2 MG/ML Injectable SolutionPSNb79b38ee-c29d-4099-964f-000031f47f5a4
238100lorazepam 2 MG/ML Injectable SolutionSCDb79b38ee-c29d-4099-964f-000031f47f5a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6207-01006416207011 mL in 1 VIAL1 mlHistorical
0641-6207-250064162072525 VIAL in 1 CARTON (0641-6207-25) / 1 mL in 1 VIAL (0641-6207-01) 25 vial1980-07-250000-00-00NoNoCurrent