Lorazepam

Product NDC
69315-906
11-digit product format
693150906
Labeler code
69315
Product ID
69315-906_40249bb6-0d25-4b2f-aa4b-85c15af6bf8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA078203
Marketing category
ANDA
Marketing start
2023-05-16
Substance
LORAZEPAM
Active strength
2 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
LORAZEPAM2 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-906-01Lorazepam100 in 1 BOTTLETABLET10013
69315-906-05Lorazepam500 in 1 BOTTLETABLET50013
69315-906-10Lorazepam1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-906-01EA - Each69315-906f9f920fb-4e29-41c8-892d-5ccd49cab66212016-06-14
69315-906-05EA - Each69315-906e770ec58-bc04-4658-a199-d2d72855685812016-06-14
69315-906-10EA - Each69315-9062ce035fb-4983-49ae-8d91-fb9cb34ce8fb12016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORAZEPAMACTIVE INGREDIENTO26FZP769LLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
LORAZEPAMACTIVE MOIETYO26FZP769LLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULORAZEPAM TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-906LORAZEPAM TABLET [LEADING PHARMA, LLC]13Current NDC, Legacy NDC, 3 package rows20231215_5ca13415-4b77-4131-a9d2-6db26bc49167.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197902LORazepam 2 MG Oral TabletPSN8e3d44fb-24b7-4552-9e95-de3bf871a88b103
197902lorazepam 2 MG Oral TabletSCD8e3d44fb-24b7-4552-9e95-de3bf871a88b103
197902LORazepam 2 MG Oral TabletPSNb707ecb2-644c-4323-ab0e-7bc5929cd56015
197902lorazepam 2 MG Oral TabletSCDb707ecb2-644c-4323-ab0e-7bc5929cd56015
197902LORazepam 2 MG Oral TabletPSN0681c8db-ff09-4258-a5e0-76a26b0ea0af14
197902LORazepam 2 MG Oral TabletPSNd6364be4-056b-4ebe-83bc-3fc85e8f488c14
197902lorazepam 2 MG Oral TabletSCDd6364be4-056b-4ebe-83bc-3fc85e8f488c14
197902lorazepam 2 MG Oral TabletSCD0681c8db-ff09-4258-a5e0-76a26b0ea0af14
197900LORazepam 0.5 MG Oral TabletPSN5ca13415-4b77-4131-a9d2-6db26bc4916713
197901LORazepam 1 MG Oral TabletPSN5ca13415-4b77-4131-a9d2-6db26bc4916713
197902LORazepam 2 MG Oral TabletPSN5ca13415-4b77-4131-a9d2-6db26bc4916713
197900lorazepam 0.5 MG Oral TabletSCD5ca13415-4b77-4131-a9d2-6db26bc4916713
197901lorazepam 1 MG Oral TabletSCD5ca13415-4b77-4131-a9d2-6db26bc4916713
197902lorazepam 2 MG Oral TabletSCD5ca13415-4b77-4131-a9d2-6db26bc4916713
197900LORazepam 0.5 MG Oral TabletPSN62f6eb3b-813d-4890-aca9-799b7fa890df11
197901LORazepam 1 MG Oral TabletPSN62f6eb3b-813d-4890-aca9-799b7fa890df11
197902LORazepam 2 MG Oral TabletPSN62f6eb3b-813d-4890-aca9-799b7fa890df11
197900lorazepam 0.5 MG Oral TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197901lorazepam 1 MG Oral TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197902lorazepam 2 MG Oral TabletSCD62f6eb3b-813d-4890-aca9-799b7fa890df11
197901LORazepam 1 MG Oral TabletPSN076179cd-0974-4153-9ac6-375e512346356
197902LORazepam 2 MG Oral TabletPSN076179cd-0974-4153-9ac6-375e512346356
197901lorazepam 1 MG Oral TabletSCD076179cd-0974-4153-9ac6-375e512346356
197902lorazepam 2 MG Oral TabletSCD076179cd-0974-4153-9ac6-375e512346356
197900LORazepam 0.5 MG Oral TabletPSNfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197901LORazepam 1 MG Oral TabletPSNfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197902LORazepam 2 MG Oral TabletPSN4a66b854-4dc1-3746-e054-00144ff8d46c4
197902LORazepam 2 MG Oral TabletPSNfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197902LORazepam 2 MG Oral TabletPSN5326789e-b64f-4b3c-98cd-0e7dcdbc5e274
197900lorazepam 0.5 MG Oral TabletSCDfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197901lorazepam 1 MG Oral TabletSCDfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197902lorazepam 2 MG Oral TabletSCD5326789e-b64f-4b3c-98cd-0e7dcdbc5e274
197902lorazepam 2 MG Oral TabletSCDfdc11b95-2233-42b4-b5f3-9390b5e9e1b24
197902lorazepam 2 MG Oral TabletSCD4a66b854-4dc1-3746-e054-00144ff8d46c4
197902LORazepam 2 MG Oral TabletPSN08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f751
197902LORazepam 2 MG Oral TabletPSN5114810c-025f-6113-e063-6294a90af5381
197902lorazepam 2 MG Oral TabletSCD08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f751
197902lorazepam 2 MG Oral TabletSCD5114810c-025f-6113-e063-6294a90af5381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-906-0169315090601100 TABLET in 1 BOTTLE (69315-906-01) 100 tablet2023-05-160000-00-00NoNoCurrent
69315-906-0569315090605500 TABLET in 1 BOTTLE (69315-906-05) 500 tablet2023-05-160000-00-00NoNoCurrent
69315-906-10693150906101000 TABLET in 1 BOTTLE (69315-906-10) 1000 tablet2023-05-160000-00-00NoNoCurrent