FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
71335-2570
11-digit product format
713352570
Labeler code
71335
Product ID
71335-2570_8518bc0c-9e98-4502-986d-5f75e8658aae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212044
Marketing category
ANDA
Marketing start
2020-05-21
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
71335-2570-1Amantadine Hydrochloride20 in 1 BOTTLECAPSULE202
71335-2570-2Amantadine Hydrochloride30 in 1 BOTTLECAPSULE302
71335-2570-3Amantadine Hydrochloride10 in 1 BOTTLECAPSULE102
71335-2570-4Amantadine Hydrochloride14 in 1 BOTTLECAPSULE142
71335-2570-5Amantadine Hydrochloride60 in 1 BOTTLECAPSULE602
71335-2570-6Amantadine Hydrochloride100 in 1 BOTTLECAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2570AMANTADINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1Current NDC, 6 package rows20250207_56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f2
849389amantadine hydrochloride 100 MG Oral CapsuleSCD56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2570-17133525700120 CAPSULE in 1 BOTTLE (71335-2570-1) 20 capsule2025-02-05NoNoCurrent
71335-2570-27133525700230 CAPSULE in 1 BOTTLE (71335-2570-2) 30 capsule2025-02-05NoNoCurrent
71335-2570-37133525700310 CAPSULE in 1 BOTTLE (71335-2570-3) 10 capsule2025-02-05NoNoCurrent
71335-2570-47133525700414 CAPSULE in 1 BOTTLE (71335-2570-4) 14 capsule2025-02-05NoNoCurrent
71335-2570-57133525700560 CAPSULE in 1 BOTTLE (71335-2570-5) 60 capsule2025-02-05NoNoCurrent
71335-2570-671335257006100 CAPSULE in 1 BOTTLE (71335-2570-6) 100 capsule2025-02-05NoNoCurrent