Lorazepam

Product NDC
0591-0241
11-digit product format
005910241
Labeler code
0591
Product ID
0591-0241_a2062d88-3cf7-4da0-9cf5-d1fa5079100d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA072927
Marketing category
ANDA
Marketing start
1991-10-31
Marketing end
2023-04-30
Substance
LORAZEPAM
Active strength
1 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
0591-0241-01EA - Each0591-02410c1de111-7094-4b61-90d9-90b38eb7d34812012-07-24
0591-0241-05EA - Each0591-024133c214fa-3123-429f-8ce1-c63d61f6756c12012-07-24
0591-0241-10EA - Each0591-02418d627f5b-78af-418c-b914-d5ff923e70d312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [STAT RX USA LLC]4
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [STAT RX USA LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [STAT RX USA LLC]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [STAT RX USA LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [STAT RX USA LLC]4
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [STAT RX USA LLC]4
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 [BLENHEIM PHARMACAL, INC.]2
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]2
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [STAT RX USA LLC]1
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [REDPHARM DRUG INC.]1
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [REDPHARM DRUG INC.]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [STAT RX USA LLC]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [REDPHARM DRUG INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [REDPHARM DRUG INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLORAZEPAM TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [REDPHARM DRUG INC.]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [A-S MEDICATION SOLUTIONS LLC]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [STAT RX USA LLC]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [REDPHARM DRUG INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSN469c9815-5139-498d-b2ba-915056c0b1b024
197901lorazepam 1 MG Oral TabletSCD469c9815-5139-498d-b2ba-915056c0b1b024
197900LORazepam 0.5 MG Oral TabletPSN84e74f60-4e4f-412f-a3ff-f3252838f3714
197901LORazepam 1 MG Oral TabletPSN84e74f60-4e4f-412f-a3ff-f3252838f3714
197900lorazepam 0.5 MG Oral TabletSCD84e74f60-4e4f-412f-a3ff-f3252838f3714
197901lorazepam 1 MG Oral TabletSCD84e74f60-4e4f-412f-a3ff-f3252838f3714
197900LORazepam 0.5 MG Oral TabletPSN0007892c-8c17-400d-b820-020aa32f433b3
197901LORazepam 1 MG Oral TabletPSN2c4635eb-3e71-4ef4-b151-2ced67a7ead23
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 TabletSCD2c4635eb-3e71-4ef4-b151-2ced67a7ead23
197901lorazepam 1 MG Oral TabletSCD0007892c-8c17-400d-b820-020aa32f433b3
197902lorazepam 2 MG Oral TabletSCD0007892c-8c17-400d-b820-020aa32f433b3
197901LORazepam 1 MG Oral TabletPSN119415c4-86cc-1626-e054-00144ff8d46c2
197901LORazepam 1 MG Oral TabletPSN266e755e-a355-4cb8-af7b-5a77693db6dc2
197901lorazepam 1 MG Oral TabletSCD119415c4-86cc-1626-e054-00144ff8d46c2
197901lorazepam 1 MG Oral TabletSCD266e755e-a355-4cb8-af7b-5a77693db6dc2
197901LORazepam 1 MG Oral TabletPSNe9f1608a-1d75-4cd0-b156-795f79c1b4de1
197901LORazepam 1 MG Oral TabletPSN463faf3c-3a5b-42a5-92bb-b1299ca296821
197901LORazepam 1 MG Oral TabletPSN3af556f7-3d8c-4079-b6bc-5051966e5f3b1
197901LORazepam 1 MG Oral TabletPSN2023747b-5775-4a7f-bc52-9ecd458fc9c11
197902LORazepam 2 MG Oral TabletPSNe9f1608a-1d75-4cd0-b156-795f79c1b4de1
197901lorazepam 1 MG Oral TabletSCD463faf3c-3a5b-42a5-92bb-b1299ca296821
197901lorazepam 1 MG Oral TabletSCD3af556f7-3d8c-4079-b6bc-5051966e5f3b1
197901lorazepam 1 MG Oral TabletSCDe9f1608a-1d75-4cd0-b156-795f79c1b4de1
197901lorazepam 1 MG Oral TabletSCD2023747b-5775-4a7f-bc52-9ecd458fc9c11
197902lorazepam 2 MG Oral TabletSCDe9f1608a-1d75-4cd0-b156-795f79c1b4de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-0241-0100591024101100 TABLET in 1 BOTTLE, PLASTIC (0591-0241-01) 100 tablet1991-10-312023-03-31NoNoCurrent
0591-0241-0500591024105500 TABLET in 1 BOTTLE, PLASTIC (0591-0241-05) 500 tablet1991-10-310000-00-00NoNoCurrent
0591-0241-10005910241101000 TABLET in 1 BOTTLE, PLASTIC (0591-0241-10) 1000 tablet1991-10-310000-00-00NoNoCurrent