FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
71335-9618
11-digit product format
713359618
Labeler code
71335
Product ID
71335-9618_a7b3fa7c-2c84-4a3a-ae2a-c0f164078999
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209047
Marketing category
ANDA
Marketing start
2017-07-31
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amantadine Hydrochloride
Listing expiration
2027-12-31

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
71335-9618-1Amantadine Hydrochloride20 in 1 BOTTLECAPSULE20103
71335-9618-2Amantadine Hydrochloride30 in 1 BOTTLECAPSULE30103
71335-9618-3Amantadine Hydrochloride10 in 1 BOTTLECAPSULE10103
71335-9618-4Amantadine Hydrochloride14 in 1 BOTTLECAPSULE14103
71335-9618-5Amantadine Hydrochloride60 in 1 BOTTLECAPSULE60103
71335-9618-6Amantadine Hydrochloride100 in 1 BOTTLECAPSULE100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9618AMANTADINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20240602_6326d7f5-4c7c-4541-8db1-c582f1525f60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN6326d7f5-4c7c-4541-8db1-c582f1525f60103
849389amantadine hydrochloride 100 MG Oral CapsuleSCD6326d7f5-4c7c-4541-8db1-c582f1525f60103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-9618-17133596180120 CAPSULE in 1 BOTTLE (71335-9618-1) 20 capsule2026-04-150000-00-00NoNoCurrent
71335-9618-27133596180230 CAPSULE in 1 BOTTLE (71335-9618-2) 30 capsule2026-04-150000-00-00NoNoCurrent
71335-9618-37133596180310 CAPSULE in 1 BOTTLE (71335-9618-3) 10 capsule2024-05-300000-00-00NoNoCurrent
71335-9618-47133596180414 CAPSULE in 1 BOTTLE (71335-9618-4) 14 capsule2026-04-150000-00-00NoNoCurrent
71335-9618-57133596180560 CAPSULE in 1 BOTTLE (71335-9618-5) 60 capsule2022-12-300000-00-00NoNoCurrent
71335-9618-671335961806100 CAPSULE in 1 BOTTLE (71335-9618-6) 100 capsule2026-04-15NoNoHistorical