FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
71205-223
11-digit product format
712050223
Labeler code
71205
Product ID
71205-223_600e1f99-3fda-4a12-8041-a4fc6dbced4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209047
Marketing category
ANDA
Marketing start
2016-06-30
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
71205-223-20Amantadine Hydrochloride20 in 1 BOTTLECAPSULE202
71205-223-30Amantadine Hydrochloride30 in 1 BOTTLECAPSULE302
71205-223-60Amantadine Hydrochloride60 in 1 BOTTLECAPSULE602
71205-223-90Amantadine Hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-223-20EA - Each71205-2238ba0716c-a5c9-4817-a7fb-a53117ce637b12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-223AMANTADINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 4 package rows20191012_f0e9b795-c0a1-4c95-928c-dacaaf9b3bb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSNf0e9b795-c0a1-4c95-928c-dacaaf9b3bb52
849389amantadine hydrochloride 100 MG Oral CapsuleSCDf0e9b795-c0a1-4c95-928c-dacaaf9b3bb52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-223-207120502232020 CAPSULE in 1 BOTTLE (71205-223-20) 20 capsule2019-02-010000-00-00NoNoCurrent
71205-223-307120502233030 CAPSULE in 1 BOTTLE (71205-223-30) 30 capsule2019-02-010000-00-00NoNoCurrent
71205-223-607120502236060 CAPSULE in 1 BOTTLE (71205-223-60) 60 capsule2019-02-010000-00-00NoNoCurrent
71205-223-907120502239090 CAPSULE in 1 BOTTLE (71205-223-90) 90 capsule2019-02-010000-00-00NoNoCurrent