AMANTADINE HYDROCHLORIDE

Product NDC
68996-102
11-digit product format
689960102
Labeler code
68996
Product ID
68996-102_222dda16-f466-409e-b816-6a67c10971af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMANTADINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
NewGen Pharmaceuticals LLC
Application
ANDA207570
Marketing category
ANDA
Marketing start
2017-02-28
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68996-102-01AMANTADINE HYDROCHLORIDE10 in 1 BLISTER PACKCAPSULE104
68996-102-01AMANTADINE HYDROCHLORIDE10 in 1 CARTONCAPSULE104
68996-102-30AMANTADINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE304
68996-102-50AMANTADINE HYDROCHLORIDE500 in 1 BOTTLE, PLASTICCAPSULE5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68996-102AMANTADINE HYDROCHLORIDE CAPSULE [NEWGEN PHARMACEUTICALS LLC]4Legacy NDC, 4 package rows20170228_b1b29997-9cdf-4b01-9791-716597148ebd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSNb1b29997-9cdf-4b01-9791-716597148ebd4
849389amantadine hydrochloride 100 MG Oral CapsuleSCDb1b29997-9cdf-4b01-9791-716597148ebd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68996-102-016899601020110 in 1 BLISTER PACKHistorical
68996-102-306899601023030 in 1 BOTTLE, PLASTICHistorical
68996-102-5068996010250500 in 1 BOTTLE, PLASTICHistorical