FDA.reportPublic FDA data

Lorazepam

Product NDC
68071-3227
11-digit product format
680713227
Labeler code
68071
Product ID
68071-3227_26d01964-0ab7-20cc-e063-6394a90a46aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA078203
Marketing category
ANDA
Marketing start
2007-10-01
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
Rxcui197901

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
68071-3227-12024-07-08C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-22024-07-08C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-32024-07-08C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-52024-07-08C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-62024-07-08C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-72024-07-08C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-92024-07-08C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-12023-01-30C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-22023-01-30C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-32023-01-30C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-52023-01-30C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-62023-01-30C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-72023-01-30C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-92023-01-30C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-12021-02-11C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-22021-02-11C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-32021-02-11C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-52021-02-11C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-62021-02-11C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-72021-02-11C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-92021-02-11C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-12021-01-29C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-22021-01-29C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-32021-01-29C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-52021-01-29C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-62021-01-29C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-72021-01-29C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only
68071-3227-92021-01-29C16284748780-1ba0f9c33-39a5-a910-e053-dadaa90a0b85Lorazepam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3227-1Lorazepam10 in 1 BOTTLETABLET105
68071-3227-2Lorazepam20 in 1 BOTTLETABLET205
68071-3227-3Lorazepam30 in 1 BOTTLETABLET305
68071-3227-5Lorazepam15 in 1 BOTTLETABLET155
68071-3227-6Lorazepam60 in 1 BOTTLETABLET605
68071-3227-7Lorazepam6 in 1 BOTTLETABLET65
68071-3227-9Lorazepam90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3227LORAZEPAM TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 7 package rows20241115_503834f9-fa2e-5e23-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN503834f9-fa2e-5e23-e054-00144ff88e885
197901lorazepam 1 MG Oral TabletSCD503834f9-fa2e-5e23-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3227-16807132270110 TABLET in 1 BOTTLE (68071-3227-1) 10 tablet2017-05-230000-00-00NoNoCurrent
68071-3227-26807132270220 TABLET in 1 BOTTLE (68071-3227-2) 20 tablet2017-05-230000-00-00NoNoCurrent
68071-3227-36807132270330 TABLET in 1 BOTTLE (68071-3227-3) 30 tablet2017-05-230000-00-00NoNoCurrent
68071-3227-56807132270515 TABLET in 1 BOTTLE (68071-3227-5) 15 tablet2017-05-230000-00-00NoNoCurrent
68071-3227-66807132270660 TABLET in 1 BOTTLE (68071-3227-6) 60 tablet2017-05-230000-00-00NoNoCurrent
68071-3227-7680713227076 TABLET in 1 BOTTLE (68071-3227-7) 6 tablet2017-05-230000-00-00NoNoCurrent
68071-3227-96807132270990 TABLET in 1 BOTTLE (68071-3227-9) 90 tablet2017-05-230000-00-00NoNoCurrent