FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
23155-362
11-digit product format
231550362
Labeler code
23155
Product ID
23155-362_fc8e4e42-8e97-41f0-aefc-2f01f65d8c6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721Product name220220224
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23155-362-012020-03-11C16284748780-19d75b9cf-fa91-f424-e053-dadaa90a57ceRx only
23155-362-032020-03-11C16284748780-19d75b9cf-fa91-f424-e053-dadaa90a57ceRx only
23155-362-052020-03-11C16284748780-19d75b9cf-fa91-f424-e053-dadaa90a57ceRx only
23155-362-012020-01-31C16284748780-19d75b9cf-fa91-f424-e053-dadaa90a57ceRx only
23155-362-032020-01-31C16284748780-19d75b9cf-fa91-f424-e053-dadaa90a57ceRx only
23155-362-052020-01-31C16284748780-19d75b9cf-fa91-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-362-01Amantadine Hydrochloride100 in 1 BOTTLECAPSULE10011
23155-362-03Amantadine Hydrochloride30 in 1 BOTTLECAPSULE3011
23155-362-05Amantadine Hydrochloride500 in 1 BOTTLECAPSULE50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-362-01EA - Each23155-362a36725d2-4db5-4143-8d1b-250a4a0ec99112017-10-13
23155-362-05EA - Each23155-36208d825df-a9b7-47e7-b4d5-239685cffbba12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-362AMANTADINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 3 package rows20250509_1b9498b7-125e-4314-baca-b62af6e5511c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN1f3c7c37-c488-4a88-8251-7db52dc03827101
849389amantadine hydrochloride 100 MG Oral CapsuleSCD1f3c7c37-c488-4a88-8251-7db52dc03827101
849389amantadine HCl 100 MG Oral CapsulePSN96aefbca-fe71-42ef-8079-d0d9e7370ccb100
849389amantadine HCl 100 MG Oral CapsulePSNa10bf8b5-bf70-4090-b4b2-a0be252b9fe4100
849389amantadine HCl 100 MG Oral CapsulePSNe3eb34af-6e25-4a3d-a7d2-e9a789e335cc100
849389amantadine hydrochloride 100 MG Oral CapsuleSCD96aefbca-fe71-42ef-8079-d0d9e7370ccb100
849389amantadine hydrochloride 100 MG Oral CapsuleSCDa10bf8b5-bf70-4090-b4b2-a0be252b9fe4100
849389amantadine hydrochloride 100 MG Oral CapsuleSCDe3eb34af-6e25-4a3d-a7d2-e9a789e335cc100
849389amantadine HCl 100 MG Oral CapsulePSN1b9498b7-125e-4314-baca-b62af6e5511c11
849389amantadine hydrochloride 100 MG Oral CapsuleSCD1b9498b7-125e-4314-baca-b62af6e5511c11
849389amantadine HCl 100 MG Oral CapsulePSNb2f7da34-ad78-4db3-9af1-bdd341e09f169
849389amantadine HCl 100 MG Oral CapsulePSNb54064bc-b3e1-4d83-be40-fcaddd2e99d09
849389amantadine hydrochloride 100 MG Oral CapsuleSCDb2f7da34-ad78-4db3-9af1-bdd341e09f169
849389amantadine hydrochloride 100 MG Oral CapsuleSCDb54064bc-b3e1-4d83-be40-fcaddd2e99d09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-362-0123155036201100 CAPSULE in 1 BOTTLE (23155-362-01) 100 capsule2017-06-120000-00-00NoNoCurrent
23155-362-032315503620330 CAPSULE in 1 BOTTLE (23155-362-03) 30 capsule2017-06-120000-00-00NoNoCurrent
23155-362-0523155036205500 CAPSULE in 1 BOTTLE (23155-362-05) 500 capsule2017-06-120000-00-00NoNoCurrent