FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
0591-4920
11-digit product format
005914920
Labeler code
0591
Product ID
0591-4920_67ce5a52-d507-4333-b0a0-b7177f896aec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA208096
Marketing category
ANDA
Marketing start
2017-01-03
Marketing end
2026-06-30
Substance
AMANTADINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amantadine Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMANTADINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM6Q1EO9TD0
Rxcui849395

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-4920-01Amantadine Hydrochloride100 in 1 BOTTLETABLET10021
0591-4920-05Amantadine Hydrochloride500 in 1 BOTTLETABLET50021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-4920-01EA - Each0591-49201cf35a18-161d-4108-a73a-d6b7704aa8fc12017-03-06
0591-4920-05EA - Each0591-4920818cafe5-10bb-4ae5-b901-c59e1f8abae612017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-4920AMANTADINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]20Current NDC, Legacy NDC, 2 package rows20240627_d9c9eaf7-dcc7-49c1-99d4-49f4dac3779f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849395amantadine HCl 100 MG Oral TabletPSNd9c9eaf7-dcc7-49c1-99d4-49f4dac3779f21
849395amantadine hydrochloride 100 MG Oral TabletSCDd9c9eaf7-dcc7-49c1-99d4-49f4dac3779f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-4920-0100591492001100 TABLET in 1 BOTTLE (0591-4920-01) 100 tablet2017-01-032026-06-30NoNoCurrent
0591-4920-0500591492005500 TABLET in 1 BOTTLE (0591-4920-05) 500 tablet2017-05-010000-00-00NoNoCurrent