FDA.reportPublic FDA data

amantadine hydrochloride

Product NDC
65841-835
11-digit product format
658410835
Labeler code
65841
Product ID
65841-835_c3ccac09-f561-4d2e-ba15-7d6149086042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
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
65841-835-01amantadine hydrochloride100 in 1 BOTTLECAPSULE1006
65841-835-05amantadine hydrochloride500 in 1 BOTTLECAPSULE5006
65841-835-06amantadine hydrochloride30 in 1 BOTTLECAPSULE306
65841-835-30amantadine hydrochloride10 in 1 BLISTER PACKCAPSULE106
65841-835-77amantadine hydrochloride10 in 1 CARTONCAPSULE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-835AMANTADINE HYDROCHLORIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 5 package rows20250410_579e6c23-6286-4b80-88de-c86c0e5cc2b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN579e6c23-6286-4b80-88de-c86c0e5cc2b26
849389amantadine hydrochloride 100 MG Oral CapsuleSCD579e6c23-6286-4b80-88de-c86c0e5cc2b26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-835-0165841083501100 CAPSULE in 1 BOTTLE (65841-835-01) 100 capsule2016-08-040000-00-00NoNoCurrent
65841-835-0565841083505500 CAPSULE in 1 BOTTLE (65841-835-05) 500 capsule2016-08-040000-00-00NoNoCurrent
65841-835-066584108350630 CAPSULE in 1 BOTTLE (65841-835-06) 30 capsule2016-08-040000-00-00NoNoCurrent
65841-835-306584108353010 in 1 BLISTER PACKHistorical
65841-835-776584108357710 BLISTER PACK in 1 CARTON (65841-835-77) / 10 CAPSULE in 1 BLISTER PACK (65841-835-30) 10 blister pack2016-08-040000-00-00NoNoCurrent