FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
71335-2664
11-digit product format
713352664
Labeler code
71335
Product ID
71335-2664_66849c62-0e93-47eb-bc5e-c12fea96d160
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209171
Marketing category
ANDA
Marketing start
2017-06-12
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
71335-2664-1Amantadine Hydrochloride20 in 1 BOTTLECAPSULE20100
71335-2664-2Amantadine Hydrochloride30 in 1 BOTTLECAPSULE30100
71335-2664-3Amantadine Hydrochloride10 in 1 BOTTLECAPSULE10100
71335-2664-4Amantadine Hydrochloride14 in 1 BOTTLECAPSULE14100
71335-2664-5Amantadine Hydrochloride60 in 1 BOTTLECAPSULE60100
71335-2664-6Amantadine Hydrochloride100 in 1 BOTTLECAPSULE100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2664-6EA - Each71335-266441e93ab9-89e3-4ccf-8ced-8be8c765ff1e12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSNe3eb34af-6e25-4a3d-a7d2-e9a789e335cc100
849389amantadine hydrochloride 100 MG Oral CapsuleSCDe3eb34af-6e25-4a3d-a7d2-e9a789e335cc100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2664-17133526640120 CAPSULE in 1 BOTTLE (71335-2664-1) 20 capsule2025-06-26NoNoHistorical
71335-2664-27133526640230 CAPSULE in 1 BOTTLE (71335-2664-2) 30 capsule2025-06-26NoNoHistorical
71335-2664-37133526640310 CAPSULE in 1 BOTTLE (71335-2664-3) 10 capsule2025-06-26NoNoHistorical
71335-2664-47133526640414 CAPSULE in 1 BOTTLE (71335-2664-4) 14 capsule2025-06-26NoNoHistorical
71335-2664-57133526640560 CAPSULE in 1 BOTTLE (71335-2664-5) 60 capsule2025-06-26NoNoHistorical
71335-2664-671335266406100 CAPSULE in 1 BOTTLE (71335-2664-6) 100 capsule2025-06-26NoNoHistorical