Lorazepam

Product NDC
64980-628
11-digit product format
649800628
Labeler code
64980
Product ID
64980-628_b47aeb6e-aa7a-469b-a709-15df0e99ea79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA218597
Marketing category
ANDA
Marketing start
2025-07-24
Substance
LORAZEPAM
Active strength
1 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
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
64980-628-01Lorazepam100 in 1 BOTTLETABLET1001
64980-628-10Lorazepam1000 in 1 BOTTLETABLET10001
64980-628-50Lorazepam500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-628-01EA - Each64980-628ab034c90-6236-40a5-8ec9-fbc30006bbe512025-08-11
64980-628-50EA - Each64980-628895ebfa6-8ad6-4c9b-b01c-2af7c97f34ac12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN386255e2-65aa-48ce-9eb1-246f1493cc141
197901LORazepam 1 MG Oral TabletPSN386255e2-65aa-48ce-9eb1-246f1493cc141
197902LORazepam 2 MG Oral TabletPSN386255e2-65aa-48ce-9eb1-246f1493cc141
197900lorazepam 0.5 MG Oral TabletSCD386255e2-65aa-48ce-9eb1-246f1493cc141
197901lorazepam 1 MG Oral TabletSCD386255e2-65aa-48ce-9eb1-246f1493cc141
197902lorazepam 2 MG Oral TabletSCD386255e2-65aa-48ce-9eb1-246f1493cc141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-628-0164980062801100 TABLET in 1 BOTTLE (64980-628-01) 100 tablet2025-07-24NoNoCurrent
64980-628-10649800628101000 TABLET in 1 BOTTLE (64980-628-10) 1000 tablet2025-07-24NoNoCurrent
64980-628-5064980062850500 TABLET in 1 BOTTLE (64980-628-50) 500 tablet2025-07-24NoNoCurrent