amantadine hydrochloride

Product NDC
69844-027
11-digit product format
698440027
Labeler code
69844
Product ID
69844-027_f517cee9-1300-4010-81a2-4302a0b6d9d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Graviti Pharmaceuticals Private Limited
Application
ANDA207571
Marketing category
ANDA
Marketing start
2017-01-31
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
No
Listing certified through
2020-12-31
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
69844-027-022021-01-29C16284748780-1ba0f9c33-4341-a910-e053-dadaa90a0b85Amantadine Hydrochloride Tablets, 100mg Rx only
69844-027-032021-01-29C16284748780-1ba0f9c33-4341-a910-e053-dadaa90a0b85Amantadine Hydrochloride Tablets, 100mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69844-027-02amantadine hydrochloride500 in 1 BOTTLETABLET5001
69844-027-03amantadine hydrochloride100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69844-027AMANTADINE HYDROCHLORIDE TABLET [GRAVITI PHARMACEUTICALS PRIVATE LIMITED]1Legacy NDC, 2 package rows20190211_e837ea34-c0cb-465a-95f8-4fcd106ce867.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849395amantadine HCl 100 MG Oral TabletPSNe837ea34-c0cb-465a-95f8-4fcd106ce8671
849395amantadine hydrochloride 100 MG Oral TabletSCDe837ea34-c0cb-465a-95f8-4fcd106ce8671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69844-027-0269844002702500 in 1 BOTTLEHistorical
69844-027-0369844002703100 in 1 BOTTLEHistorical