FDA.reportPublic FDA data

Lorazepam

Product NDC
33261-364
11-digit product format
332610364
Labeler code
33261
Product ID
33261-364_42ce3852-92b2-4637-89cf-a85b2e106ccf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078203
Marketing category
ANDA
Marketing start
2007-10-01
Marketing end
0000-00-00
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-364-302020-01-31C16284748780-19d75b9d1-24d2-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV Rx only
33261-364-402020-01-31C16284748780-19d75b9d1-24d2-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV Rx only
33261-364-602020-01-31C16284748780-19d75b9d1-24d2-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-364-30Lorazepam30 in 1 BOTTLE, PLASTICTABLET301
33261-364-40Lorazepam40 in 1 BOTTLE, PLASTICTABLET401
33261-364-60Lorazepam60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-364-30EA - Each33261-36466e41d17-6336-4a2e-88e1-b3a4f1adafd412015-10-02
33261-364-40EA - Each33261-364e9709e49-ceca-47cc-af9c-308c08a9747a12016-09-02
33261-364-60EA - Each33261-364e766ea8a-691b-4501-9480-147df0538f0b12015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-364LORAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140128_ef3b64e1-4a79-44c4-b73a-0a86a1f910b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSNef3b64e1-4a79-44c4-b73a-0a86a1f910b41
197901LORazepam 1 MG Oral TabletPSNef3b64e1-4a79-44c4-b73a-0a86a1f910b41
197902LORazepam 2 MG Oral TabletPSNef3b64e1-4a79-44c4-b73a-0a86a1f910b41
197900lorazepam 0.5 MG Oral TabletSCDef3b64e1-4a79-44c4-b73a-0a86a1f910b41
197901lorazepam 1 MG Oral TabletSCDef3b64e1-4a79-44c4-b73a-0a86a1f910b41
197902lorazepam 2 MG Oral TabletSCDef3b64e1-4a79-44c4-b73a-0a86a1f910b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-364-303326103643030 in 1 BOTTLE, PLASTICHistorical
33261-364-403326103644040 in 1 BOTTLE, PLASTICHistorical
33261-364-603326103646060 in 1 BOTTLE, PLASTICHistorical