FDA.reportPublic FDA data

Lorazepam

Product NDC
63304-773
11-digit product format
633040773
Labeler code
63304
Product ID
63304-773_b8fbb599-96d9-4866-908d-d8be424e5ee3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
SUN PHARMACEUTICAL INDUSTRIES INC
Application
ANDA076045
Marketing category
ANDA
Marketing start
2023-06-25
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lorazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui197900, 197901, 197902

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
63304-773-012023-07-06C16284748780-19d75b9d0-c031-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV
63304-773-052023-07-06C16284748780-19d75b9d0-c031-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV
63304-773-102023-07-06C16284748780-19d75b9d0-c031-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV
63304-773-302023-07-06C16284748780-19d75b9d0-c031-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV
63304-773-902023-07-06C16284748780-19d75b9d0-c031-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV
63304-773-012020-01-31C16284748780-19d75b9d0-c031-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV
63304-773-052020-01-31C16284748780-19d75b9d0-c031-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV
63304-773-102020-01-31C16284748780-19d75b9d0-c031-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV
63304-773-302020-01-31C16284748780-19d75b9d0-c031-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV
63304-773-902020-01-31C16284748780-19d75b9d0-c031-f424-e053-dadaa90a57ceLorazepam Tablets, USP CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-773-01Lorazepam100 in 1 BOTTLETABLET1004
63304-773-05Lorazepam500 in 1 BOTTLETABLET5004
63304-773-10Lorazepam1000 in 1 BOTTLETABLET10004
63304-773-90Lorazepam90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-773-01EA - Each63304-77310fdf5c1-76ba-40db-8b19-252f4302513812012-07-24
63304-773-05EA - Each63304-77306257916-141e-4460-9fc7-0f188d3e21f712012-07-24
63304-773-10EA - Each63304-7733887bd67-940a-44ca-ab43-624f3341c58312012-07-24
63304-773-90EA - Each63304-7739b088c62-8165-4a48-b461-8c503187c69b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [TYA PHARMACEUTICALS]4
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [TYA PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [TYA PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORAZEPAM TABLET [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [TYA PHARMACEUTICALS]4
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [TYA PHARMACEUTICALS]4
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [RANBAXY PHARMACEUTICALS INC.]3
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [RANBAXY PHARMACEUTICALS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [RANBAXY PHARMACEUTICALS INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORAZEPAM TABLET [RANBAXY PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [RANBAXY PHARMACEUTICALS INC.]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [RANBAXY PHARMACEUTICALS INC.]3
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
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
63304-773LORAZEPAM TABLET [SUN PHARMACEUTICAL INDUSTRIES INC]4Current NDC, Legacy NDC, 4 package rows20230707_0c1caa9c-9ef1-459c-86c3-adb939130a9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197900LORazepam 0.5 MG Oral TabletPSN08a30230-fc95-9025-e063-6394a90ae21b16
197901LORazepam 1 MG Oral TabletPSN08a30230-fc95-9025-e063-6394a90ae21b16
197902LORazepam 2 MG Oral TabletPSN08a30230-fc95-9025-e063-6394a90ae21b16
197900lorazepam 0.5 MG Oral TabletSCD08a30230-fc95-9025-e063-6394a90ae21b16
197901lorazepam 1 MG Oral TabletSCD08a30230-fc95-9025-e063-6394a90ae21b16
197902lorazepam 2 MG Oral TabletSCD08a30230-fc95-9025-e063-6394a90ae21b16
197900LORazepam 0.5 MG Oral TabletPSN0a145ba5-be21-49c4-a036-baa81c88e5f24
197900LORazepam 0.5 MG Oral TabletPSN0c1caa9c-9ef1-459c-86c3-adb939130a9f4
197901LORazepam 1 MG Oral TabletPSN0a145ba5-be21-49c4-a036-baa81c88e5f24
197901LORazepam 1 MG Oral TabletPSN0c1caa9c-9ef1-459c-86c3-adb939130a9f4
197902LORazepam 2 MG Oral TabletPSN0c1caa9c-9ef1-459c-86c3-adb939130a9f4
197900lorazepam 0.5 MG Oral TabletSCD0a145ba5-be21-49c4-a036-baa81c88e5f24
197900lorazepam 0.5 MG Oral TabletSCD0c1caa9c-9ef1-459c-86c3-adb939130a9f4
197901lorazepam 1 MG Oral TabletSCD0a145ba5-be21-49c4-a036-baa81c88e5f24
197901lorazepam 1 MG Oral TabletSCD0c1caa9c-9ef1-459c-86c3-adb939130a9f4
197902lorazepam 2 MG Oral TabletSCD0c1caa9c-9ef1-459c-86c3-adb939130a9f4
197901LORazepam 1 MG Oral TabletPSN86630bdd-13ad-4ab5-9e94-fcf2ea2113e13
197901lorazepam 1 MG Oral TabletSCD86630bdd-13ad-4ab5-9e94-fcf2ea2113e13
197901LORazepam 1 MG Oral TabletPSNa243952c-0792-4a08-9fb5-a63dc0359fe72
197901lorazepam 1 MG Oral TabletSCDa243952c-0792-4a08-9fb5-a63dc0359fe72
197900LORazepam 0.5 MG Oral TabletPSNebdf72f7-7462-4b83-81b4-c7988860c7281
197901LORazepam 1 MG Oral TabletPSN46238e9c-cf5b-4dc0-b8b4-d0203913f1dd1
197901LORazepam 1 MG Oral TabletPSNebdf72f7-7462-4b83-81b4-c7988860c7281
197902LORazepam 2 MG Oral TabletPSNebdf72f7-7462-4b83-81b4-c7988860c7281
197900lorazepam 0.5 MG Oral TabletSCDebdf72f7-7462-4b83-81b4-c7988860c7281
197901lorazepam 1 MG Oral TabletSCD46238e9c-cf5b-4dc0-b8b4-d0203913f1dd1
197901lorazepam 1 MG Oral TabletSCDebdf72f7-7462-4b83-81b4-c7988860c7281
197902lorazepam 2 MG Oral TabletSCDebdf72f7-7462-4b83-81b4-c7988860c7281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63304-773-0163304077301100 TABLET in 1 BOTTLE (63304-773-01) 100 tablet2023-06-25NoNoCurrent
63304-773-0563304077305500 TABLET in 1 BOTTLE (63304-773-05) 500 tablet2023-06-25NoNoCurrent
63304-773-10633040773101000 TABLET in 1 BOTTLE (63304-773-10) 1000 tablet2023-06-25NoNoCurrent
63304-773-906330407739090 TABLET in 1 BOTTLE (63304-773-90) 90 tablet2023-06-25NoNoCurrent