FDA.reportPublic FDA data

Lorazepam

Product NDC
72789-356
11-digit product format
727890356
Labeler code
72789
Product ID
72789-356_3ba0f2b6-845e-8fdb-e063-6394a90a4502
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076045
Marketing category
ANDA
Marketing start
2023-10-26
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
72789-356-01Lorazepam100 in 1 BOTTLE, PLASTICTABLET10016
72789-356-30Lorazepam30 in 1 BOTTLE, PLASTICTABLET3016
72789-356-60Lorazepam60 in 1 BOTTLE, PLASTICTABLET6016
72789-356-90Lorazepam90 in 1 BOTTLE, PLASTICTABLET9016
72789-356-95Lorazepam1000 in 1 BOTTLE, PLASTICTABLET100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-356-01EA - Each72789-3562461148c-eade-41c9-9c5c-41bcda1de88512025-06-13
72789-356-30EA - Each72789-3562039ce23-6ee6-4458-b559-5e2b523dcab212023-12-05
72789-356-60EA - Each72789-356dadad6a7-a559-44be-8e80-46375c4a192c12023-12-05
72789-356-90EA - Each72789-3568b07909b-8532-4f7d-87ca-ae602d66919212023-12-05
72789-356-95EA - Each72789-356feebbfeb-1fcc-4e1b-b869-9c2bf670ec2012023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-356LORAZEPAM TABLET [PD-RX PHARMACEUTICALS, INC.]15Current NDC, 5 package rows20250507_08a30230-fc95-9025-e063-6394a90ae21b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN08a30230-fc95-9025-e063-6394a90ae21b16
197901LORazepam 1 MG Oral TabletPSN08a30230-fc95-9025-e063-6394a90ae21b16
197902LORazepam 2 MG Oral TabletPSN08a30230-fc95-9025-e063-6394a90ae21b16
197900lorazepam 0.5 MG Oral TabletSCD08a30230-fc95-9025-e063-6394a90ae21b16
197901lorazepam 1 MG Oral TabletSCD08a30230-fc95-9025-e063-6394a90ae21b16
197902lorazepam 2 MG Oral TabletSCD08a30230-fc95-9025-e063-6394a90ae21b16
197901LORazepam 1 MG Oral TabletPSN1791d5c9-9004-5c4b-e063-6294a90adf3d4
197901lorazepam 1 MG Oral TabletSCD1791d5c9-9004-5c4b-e063-6294a90adf3d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-356-0172789035601100 TABLET in 1 BOTTLE, PLASTIC (72789-356-01) 100 tablet2025-05-05NoNoCurrent
72789-356-307278903563030 TABLET in 1 BOTTLE, PLASTIC (72789-356-30) 30 tablet2023-10-26NoNoCurrent
72789-356-607278903566060 TABLET in 1 BOTTLE, PLASTIC (72789-356-60) 60 tablet2023-10-26NoNoCurrent
72789-356-907278903569090 TABLET in 1 BOTTLE, PLASTIC (72789-356-90) 90 tablet2023-10-26NoNoCurrent
72789-356-95727890356951000 TABLET in 1 BOTTLE, PLASTIC (72789-356-95) 1000 tablet2023-10-26NoNoCurrent