FDA.reportPublic FDA data

Amantadine HCL

Product NDC
72189-657
11-digit product format
721890657
Labeler code
72189
Product ID
72189-657_487125c0-51e8-aea3-e063-6394a90a6930
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct RX
Application
ANDA210129
Marketing category
ANDA
Marketing start
2026-01-15
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
2027-12-31
Current FDA listing
Yes

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
72189-657-30Amantadine HCL30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-657-30EA - Each72189-6578b032c12-d429-4777-8a01-73c32b93ac5a12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
72189-657-307218906573030 CAPSULE in 1 BOTTLE (72189-657-30) 30 capsule2026-01-15NoNoHistorical