Lorazepam

Product NDC
0591-0242
11-digit product format
005910242
Labeler code
0591
Product ID
0591-0242_a2062d88-3cf7-4da0-9cf5-d1fa5079100d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA072928
Marketing category
ANDA
Marketing start
1991-10-31
Marketing end
2022-11-30
Substance
LORAZEPAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
0000-00-00
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0242-01EA - Each0591-0242566eba1a-ac4e-4f5c-9099-7566c5c135b912012-07-24
0591-0242-05EA - Each0591-02428ae0bbaf-c55e-4fba-8b17-c96b564cef9912012-07-24
0591-0242-10EA - Each0591-02421c9a265f-d964-4eea-81ad-9aff295ab93b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [PHYSICIANS TOTAL CARE, INC.]3
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [TYA PHARMACEUTICALS]2
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [TYA PHARMACEUTICALS]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [TYA PHARMACEUTICALS]2
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [TYA PHARMACEUTICALS]2
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [STAT RX USA LLC]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [STAT RX USA LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [STAT RX USA LLC]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN0007892c-8c17-400d-b820-020aa32f433b3
197901LORazepam 1 MG Oral TabletPSN0007892c-8c17-400d-b820-020aa32f433b3
197902LORazepam 2 MG Oral TabletPSN0007892c-8c17-400d-b820-020aa32f433b3
197900lorazepam 0.5 MG Oral TabletSCD0007892c-8c17-400d-b820-020aa32f433b3
197901lorazepam 1 MG Oral TabletSCD0007892c-8c17-400d-b820-020aa32f433b3
197902lorazepam 2 MG Oral TabletSCD0007892c-8c17-400d-b820-020aa32f433b3
197902LORazepam 2 MG Oral TabletPSNc90ded6a-067b-4460-a456-9065ec8f7e1b2
197902lorazepam 2 MG Oral TabletSCDc90ded6a-067b-4460-a456-9065ec8f7e1b2
197901LORazepam 1 MG Oral TabletPSNe9f1608a-1d75-4cd0-b156-795f79c1b4de1
197902LORazepam 2 MG Oral TabletPSNd88ec7fd-89b4-48c0-98cb-e341341465401
197902LORazepam 2 MG Oral TabletPSNe9f1608a-1d75-4cd0-b156-795f79c1b4de1
197901lorazepam 1 MG Oral TabletSCDe9f1608a-1d75-4cd0-b156-795f79c1b4de1
197902lorazepam 2 MG Oral TabletSCDd88ec7fd-89b4-48c0-98cb-e341341465401
197902lorazepam 2 MG Oral TabletSCDe9f1608a-1d75-4cd0-b156-795f79c1b4de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-0242-0100591024201100 TABLET in 1 BOTTLE, PLASTIC (0591-0242-01) 100 tablet1991-10-312022-11-30NoNoCurrent
0591-0242-0500591024205500 TABLET in 1 BOTTLE, PLASTIC (0591-0242-05) 500 tablet1991-10-312022-11-30NoNoCurrent
0591-0242-10005910242101000 TABLET in 1 BOTTLE, PLASTIC (0591-0242-10) 1000 tablet1991-10-312022-11-30NoNoCurrent