FDA.reportPublic FDA data

Lorazepam

Product NDC
71335-0329
11-digit product format
713350329
Labeler code
71335
Product ID
71335-0329_1577a3f6-8289-4621-a0e5-9d69bc6218d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078203
Marketing category
ANDA
Marketing start
2023-05-16
Substance
LORAZEPAM
Active strength
.5 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
LORAZEPAM.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui197900

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0329-12024-05-15C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-22024-05-15C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-32024-05-15C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-42024-05-15C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-52024-05-15C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-62024-05-15C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-72024-05-15C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-82024-05-15C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-92024-05-15C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-12024-01-30C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-22024-01-30C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-32024-01-30C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-42024-01-30C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-52024-01-30C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-62024-01-30C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-72024-01-30C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-82024-01-30C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only
71335-0329-92024-01-30C16284748780-11030e365-0db3-111a-e063-dadaa90a10e2Lorazepam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0329-1Lorazepam30 in 1 BOTTLETABLET3011
71335-0329-2Lorazepam10 in 1 BOTTLETABLET1011
71335-0329-3Lorazepam60 in 1 BOTTLETABLET6011
71335-0329-4Lorazepam90 in 1 BOTTLETABLET9011
71335-0329-5Lorazepam15 in 1 BOTTLETABLET1511
71335-0329-6Lorazepam100 in 1 BOTTLETABLET10011
71335-0329-7Lorazepam120 in 1 BOTTLETABLET12011
71335-0329-8Lorazepam2 in 1 BOTTLETABLET211
71335-0329-9Lorazepam5 in 1 BOTTLETABLET511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0329-1EA - Each71335-032938a4d62c-689e-47b7-a3e5-53641cca1d6d12018-02-20
71335-0329-2EA - Each71335-03291c7b1946-7757-4298-9c06-15e89dabf6f312018-02-20
71335-0329-3EA - Each71335-0329edc95b78-ed4c-4197-ab91-fb459cce27cc12018-02-20
71335-0329-4EA - Each71335-032935a4a9e0-0cc7-4a0e-9c03-157030c1ee9c12018-02-20
71335-0329-5EA - Each71335-03294f90930d-99f2-4f2a-a22a-b316ca4e6e7612018-02-20
71335-0329-6EA - Each71335-032950e35d7a-2628-4442-982a-8e5c7b420e6f12018-02-20
71335-0329-7EA - Each71335-03293fce819a-057c-4014-b77b-19a2b402a10712018-02-20
71335-0329-8EA - Each71335-03293098f120-4cf5-4d5b-902a-d9ed7b64422f12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0329LORAZEPAM TABLET [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 9 package rows20240517_aac672f9-0ba7-4852-b8a7-caac9e4b1e77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSNaac672f9-0ba7-4852-b8a7-caac9e4b1e7711
197900lorazepam 0.5 MG Oral TabletSCDaac672f9-0ba7-4852-b8a7-caac9e4b1e7711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0329-17133503290130 TABLET in 1 BOTTLE (71335-0329-1) 30 tablet2024-05-150000-00-00NoNoCurrent
71335-0329-27133503290210 TABLET in 1 BOTTLE (71335-0329-2) 10 tablet2024-05-150000-00-00NoNoCurrent
71335-0329-37133503290360 TABLET in 1 BOTTLE (71335-0329-3) 60 tablet2024-05-150000-00-00NoNoCurrent
71335-0329-47133503290490 TABLET in 1 BOTTLE (71335-0329-4) 90 tablet2024-05-150000-00-00NoNoCurrent
71335-0329-57133503290515 TABLET in 1 BOTTLE (71335-0329-5) 15 tablet2024-05-150000-00-00NoNoCurrent
71335-0329-671335032906100 TABLET in 1 BOTTLE (71335-0329-6) 100 tablet2024-05-150000-00-00NoNoCurrent
71335-0329-771335032907120 TABLET in 1 BOTTLE (71335-0329-7) 120 tablet2024-05-150000-00-00NoNoCurrent
71335-0329-8713350329082 TABLET in 1 BOTTLE (71335-0329-8) 2 tablet2024-05-150000-00-00NoNoCurrent
71335-0329-9713350329095 TABLET in 1 BOTTLE (71335-0329-9) 5 tablet2024-05-150000-00-00NoNoCurrent