Lorazepam

Product NDC
10544-085
11-digit product format
105440085
Labeler code
10544
Product ID
10544-085_b9265fa0-135e-487b-a5e0-537ec64890f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA076045
Marketing category
ANDA
Marketing start
2012-09-04
Marketing end
0000-00-00
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
10544-085-302020-01-31C16284748780-19d75b9d1-28f2-f424-e053-dadaa90a57ceLORAZEPAM TABLETS, USP C-IV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-085-30Lorazepam30 in 1 BOTTLETABLET302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-085LORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20150801_a243952c-0792-4a08-9fb5-a63dc0359fe7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSNa243952c-0792-4a08-9fb5-a63dc0359fe72
197901lorazepam 1 MG Oral TabletSCDa243952c-0792-4a08-9fb5-a63dc0359fe72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-085-301054400853030 in 1 BOTTLEHistorical