AMANTADINE HYDROCHLORIDE

Product NDC
24689-105
11-digit product format
246890105
Labeler code
24689
Product ID
24689-105_d4595cc8-7960-6c44-e053-2995a90adb3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
APNAR PHARMA LP
Application
ANDA210129
Marketing category
ANDA
Marketing start
2022-01-20
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24689-105-01AMANTADINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1002
24689-105-02AMANTADINE HYDROCHLORIDE500 in 1 BOTTLECAPSULE5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-105AMANTADINE HYDROCHLORIDE CAPSULE [APNAR PHARMA LP]2Legacy NDC, 2 package rows20240601_d4595cc8-795f-6c44-e053-2995a90adb3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSNd4595cc8-795f-6c44-e053-2995a90adb3e2
849389amantadine hydrochloride 100 MG Oral CapsuleSCDd4595cc8-795f-6c44-e053-2995a90adb3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24689-105-0124689010501100 CAPSULE in 1 BOTTLE (24689-105-01) 100 capsule2022-01-200000-00-00NoNoCurrent
24689-105-0224689010502500 CAPSULE in 1 BOTTLE (24689-105-02) 500 capsule2022-01-200000-00-00NoNoCurrent