FDA.reportPublic FDA data

amantadine hydrochloride

Product NDC
71335-0469
11-digit product format
713350469
Labeler code
71335
Product ID
71335-0469_3ef002b2-c3df-4474-92d6-940444cc9415
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208278
Marketing category
ANDA
Marketing start
2016-08-04
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
amantadine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMANTADINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM6Q1EO9TD0
Rxcui849389

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
71335-0469-1amantadine hydrochloride20 in 1 BOTTLECAPSULE208
71335-0469-2amantadine hydrochloride30 in 1 BOTTLECAPSULE308
71335-0469-3amantadine hydrochloride10 in 1 BOTTLECAPSULE108
71335-0469-4amantadine hydrochloride14 in 1 BOTTLECAPSULE148
71335-0469-5amantadine hydrochloride60 in 1 BOTTLECAPSULE608
71335-0469-6amantadine hydrochloride100 in 1 BOTTLECAPSULE1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0469AMANTADINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 6 package rows20231206_8e578f11-6112-4a1f-8de4-a76870bb62c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN8e578f11-6112-4a1f-8de4-a76870bb62c78
849389amantadine hydrochloride 100 MG Oral CapsuleSCD8e578f11-6112-4a1f-8de4-a76870bb62c78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0469-17133504690120 CAPSULE in 1 BOTTLE (71335-0469-1) 20 capsule2021-12-270000-00-00NoNoCurrent
71335-0469-27133504690230 CAPSULE in 1 BOTTLE (71335-0469-2) 30 capsule2021-08-300000-00-00NoNoCurrent
71335-0469-37133504690310 CAPSULE in 1 BOTTLE (71335-0469-3) 10 capsule2021-12-270000-00-00NoNoCurrent
71335-0469-47133504690414 CAPSULE in 1 BOTTLE (71335-0469-4) 14 capsule2018-10-220000-00-00NoNoCurrent
71335-0469-57133504690560 CAPSULE in 1 BOTTLE (71335-0469-5) 60 capsule2020-08-050000-00-00NoNoCurrent
71335-0469-671335046906100 CAPSULE in 1 BOTTLE (71335-0469-6) 100 capsule2020-08-05NoNoCurrent