AMANTADINE HYDROCHLORIDE

Product NDC
68996-101
11-digit product format
689960101
Labeler code
68996
Product ID
68996-101_8545d964-dfda-4483-94f6-2399179d71b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMANTADINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
NewGen Pharmaceuticals LLC
Application
ANDA207571
Marketing category
ANDA
Marketing start
2017-03-01
Marketing end
0000-00-00
Substance
AMANTADINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
519d6abc-639d-2962-cced-abbf8b16aad4Product name720250401
82f46845-b4c7-48da-a389-ba5721b956c9Product name220250325
d2c037c0-5ebf-d224-252f-2549922c21c7Product name720240208
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721Product name220220224
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68996-101-302020-01-31C16284748780-19d75b9cf-fdb8-f424-e053-dadaa90a57ce50674b1c-ebae-4356-8872-36d298cecdb3
68996-101-502020-01-31C16284748780-19d75b9cf-fdb8-f424-e053-dadaa90a57ce50674b1c-ebae-4356-8872-36d298cecdb3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68996-101-30AMANTADINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET303
68996-101-50AMANTADINE HYDROCHLORIDE500 in 1 BOTTLE, PLASTICTABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68996-101AMANTADINE HYDROCHLORIDE TABLET [NEWGEN PHARMACEUTICALS LLC]3Legacy NDC, 2 package rows20170301_50674b1c-ebae-4356-8872-36d298cecdb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849395amantadine HCl 100 MG Oral TabletPSN50674b1c-ebae-4356-8872-36d298cecdb33
849395amantadine hydrochloride 100 MG Oral TabletSCD50674b1c-ebae-4356-8872-36d298cecdb33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68996-101-306899601013030 in 1 BOTTLE, PLASTICHistorical
68996-101-5068996010150500 in 1 BOTTLE, PLASTICHistorical