FDA.reportPublic FDA data

amantadine hydrochloride

Product NDC
71205-702
11-digit product format
712050702
Labeler code
71205
Product ID
71205-702_743d1b73-f47e-4bbf-bb52-45b1e7f17308
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
71205-702-20amantadine hydrochloride20 in 1 BOTTLECAPSULE201
71205-702-30amantadine hydrochloride30 in 1 BOTTLECAPSULE301
71205-702-60amantadine hydrochloride60 in 1 BOTTLECAPSULE601
71205-702-90amantadine hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-702-20EA - Each71205-7028c51bec4-141a-4ce1-afb6-2fb3714baa9212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-702AMANTADINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 4 package rows20221001_743d1b73-f47e-4bbf-bb52-45b1e7f17308.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN743d1b73-f47e-4bbf-bb52-45b1e7f173081
849389amantadine hydrochloride 100 MG Oral CapsuleSCD743d1b73-f47e-4bbf-bb52-45b1e7f173081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-702-207120507022020 CAPSULE in 1 BOTTLE (71205-702-20) 20 capsule2022-09-290000-00-00NoNoCurrent
71205-702-307120507023030 CAPSULE in 1 BOTTLE (71205-702-30) 30 capsule2022-09-290000-00-00NoNoCurrent
71205-702-607120507026060 CAPSULE in 1 BOTTLE (71205-702-60) 60 capsule2022-09-290000-00-00NoNoCurrent
71205-702-907120507029090 CAPSULE in 1 BOTTLE (71205-702-90) 90 capsule2022-09-290000-00-00NoNoCurrent