FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
16571-834
11-digit product format
165710834
Labeler code
16571
Product ID
16571-834_1a920249-de25-4d4e-b515-4fcbf3ead399
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA210129
Marketing category
ANDA
Marketing start
2022-09-05
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
16571-834-01Amantadine Hydrochloride100 in 1 BOTTLECAPSULE1003
16571-834-50Amantadine Hydrochloride500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-834-01EA - Each16571-83481f7a27a-e3e0-4480-83d3-493122fb40a812022-10-06
16571-834-50EA - Each16571-8347e101eb2-a113-4a00-a121-cabd1e9e9d7012022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-834AMANTADINE HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 2 package rows20250411_6fd54e00-a714-4442-af95-2515ab3b2ac3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN6fd54e00-a714-4442-af95-2515ab3b2ac33
849389amantadine hydrochloride 100 MG Oral CapsuleSCD6fd54e00-a714-4442-af95-2515ab3b2ac33
849389amantadine HCl 100 MG Oral CapsulePSN487125c0-51e7-aea3-e063-6394a90a69301
849389amantadine hydrochloride 100 MG Oral CapsuleSCD487125c0-51e7-aea3-e063-6394a90a69301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-834-0116571083401100 CAPSULE in 1 BOTTLE (16571-834-01) 100 capsule2022-09-050000-00-00NoNoCurrent
16571-834-5016571083450500 CAPSULE in 1 BOTTLE (16571-834-50) 500 capsule2022-09-050000-00-00NoNoCurrent