FDA.reportPublic FDA data

Lorazepam

Product NDC
70518-2186
11-digit product format
705182186
Labeler code
70518
Product ID
70518-2186_38cb5e7e-0bdb-3d40-e063-6294a90a0d1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lorazepam
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078203
Marketing category
ANDA
Marketing start
2019-07-02
Marketing end
2026-08-31
Substance
LORAZEPAM
Active strength
1 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lorazepam

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORAZEPAM1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO26FZP769L
Rxcui197901

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
70518-2186-02023-03-08C16284748780-1f386c649-caa6-0266-e053-dadaa90a7c1aLorazepam Tablets, USP CIV Rx only
70518-2186-02023-01-30C16284748780-1f386c649-caa6-0266-e053-dadaa90a7c1aLorazepam Tablets, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2186-0Lorazepam100 in 1 BOXTABLET1009
70518-2186-1Lorazepam1 in 1 POUCHTABLET19
70518-2186-2Lorazepam30 in 1 BLISTER PACKTABLET309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2186LORAZEPAM TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 3 package rows20240622_eb068a0f-5c0e-4218-b4c5-a0d0b1d362bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197901LORazepam 1 MG Oral TabletPSNeb068a0f-5c0e-4218-b4c5-a0d0b1d362bd9
197901lorazepam 1 MG Oral TabletSCDeb068a0f-5c0e-4218-b4c5-a0d0b1d362bd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2186-070518218600100 POUCH in 1 BOX (70518-2186-0) > 1 TABLET in 1 POUCH (70518-2186-1) 100 pouch2019-07-020000-00-00NoNoCurrent
70518-2186-1705182186011 in 1 POUCHHistorical
70518-2186-27051821860230 TABLET in 1 BLISTER PACK (70518-2186-2) 30 tablet2024-06-212026-08-31NoNoHistorical