Lorazepam

Product NDC
12634-867
11-digit product format
126340867
Labeler code
12634
Product ID
12634-867_5f71530d-599c-4eb7-bbf4-716dfdfd09ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca, Inc
Application
ANDA076045
Marketing category
ANDA
Marketing start
2001-12-11
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
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-867-00Lorazepam10 in 1 BOTTLETABLET101
12634-867-71Lorazepam30 in 1 BOTTLETABLET301
12634-867-91Lorazepam1 in 1 BLISTER PACKTABLET11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [APOTHECA, INC]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [APOTHECA, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [APOTHECA, INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORAZEPAM TABLET [APOTHECA, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [APOTHECA, INC]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [APOTHECA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-867LORAZEPAM TABLET [APOTHECA, INC]1Legacy NDC, 3 package rows20141023_46238e9c-cf5b-4dc0-b8b4-d0203913f1dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN46238e9c-cf5b-4dc0-b8b4-d0203913f1dd1
197901lorazepam 1 MG Oral TabletSCD46238e9c-cf5b-4dc0-b8b4-d0203913f1dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-867-001263408670010 in 1 BOTTLEHistorical
12634-867-711263408677130 in 1 BOTTLEHistorical
12634-867-91126340867911 in 1 BLISTER PACKHistorical