FDA.reportPublic FDA data

AMANTADINE HYDROCHLORIDE

Product NDC
50436-0646
11-digit product format
504360646
Labeler code
50436
Product ID
50436-0646_d33c04f9-0d0f-474a-8395-1a3f62adfa5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMANTADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA074509
Marketing category
ANDA
Marketing start
1995-07-17
Marketing end
0000-00-00
Substance
AMANTADINE HYDROCHLORIDE
Active strength
50 mg/5mL
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
50436-0646-12021-01-29C16284748780-1ba0f9c33-41a0-a910-e053-dadaa90a0b85Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0646-1AMANTADINE HYDROCHLORIDE5 mL in 1 CUP, UNIT-DOSESOLUTION54
50436-0646-1AMANTADINE HYDROCHLORIDE72 in 1 CASESOLUTION724

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0646AMANTADINE HYDROCHLORIDE SOLUTION [UNIT DOSE SERVICES]4Legacy NDC, 2 package rows20180412_e62c3ce4-af0a-4e5e-82ab-c74fd65449ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSNe62c3ce4-af0a-4e5e-82ab-c74fd65449ac4
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCDe62c3ce4-af0a-4e5e-82ab-c74fd65449ac4
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSYe62c3ce4-af0a-4e5e-82ab-c74fd65449ac4
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSYe62c3ce4-af0a-4e5e-82ab-c74fd65449ac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-0646-1504360646015 mL in 1 CUP, UNIT-DOSE5 mlHistorical