FDA.reportPublic FDA data

Lorazepam

Product NDC
70518-1045
11-digit product format
705181045
Labeler code
70518
Product ID
70518-1045_69fd6877-e283-e5c3-e053-2a91aa0ac017
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LORAZEPAM
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA074282
Marketing category
ANDA
Marketing start
2018-03-01
Marketing end
0000-00-00
Substance
LORAZEPAM
Active strength
2 mg/mL
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ac8efea8-f412-295f-00ce-b095e5cbc115Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1045-02025-11-11C16284748780-19d75b9cf-ce96-f424-e053-dadaa90a57ceLORAZEPAM Injection, USP
70518-1045-02020-01-31C16284748780-19d75b9cf-ce96-f424-e053-dadaa90a57ceLORAZEPAM Injection, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1045LORAZEPAM INJECTION, SOLUTION [REMEDYREPACK INC.]1Legacy NDC20180417_4489a72f-5fd0-42e5-859b-8530d500a562.zip