FDA.reportPublic FDA data

amantadine

Product NDC
62332-246
11-digit product format
623320246
Labeler code
62332
Product ID
62332-246_416dbd88-4408-43c2-b47d-c14911c050d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA208966
Marketing category
ANDA
Marketing start
2017-06-22
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
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
62332-246-30amantadine30 in 1 BOTTLECAPSULE3011
62332-246-31amantadine100 in 1 BOTTLECAPSULE10011
62332-246-71amantadine500 in 1 BOTTLECAPSULE50011
62332-246-91amantadine1000 in 1 BOTTLECAPSULE100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-246-31EA - Each62332-246b586a0cc-ac7f-4aef-bda3-604a9ef7e2cc12017-07-07
62332-246-71EA - Each62332-246b0e16a5b-59c5-486b-b043-12b21e8ff48412017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-246AMANTADINE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 4 package rows20250521_4157d9a7-a53f-4dde-b051-fe3e9a674913.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN4157d9a7-a53f-4dde-b051-fe3e9a67491311
849389amantadine hydrochloride 100 MG Oral CapsuleSCD4157d9a7-a53f-4dde-b051-fe3e9a67491311
849389amantadine HCl 100 MG Oral CapsulePSN5119801d-a5cb-4adf-96b2-08cc3a0ba5945
849389amantadine hydrochloride 100 MG Oral CapsuleSCD5119801d-a5cb-4adf-96b2-08cc3a0ba5945

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-246-306233202463030 CAPSULE in 1 BOTTLE (62332-246-30) 30 capsule2017-06-220000-00-00NoNoCurrent
62332-246-3162332024631100 CAPSULE in 1 BOTTLE (62332-246-31) 100 capsule2017-06-220000-00-00NoNoCurrent
62332-246-7162332024671500 CAPSULE in 1 BOTTLE (62332-246-71) 500 capsule2017-06-220000-00-00NoNoCurrent
62332-246-91623320246911000 CAPSULE in 1 BOTTLE (62332-246-91) 1000 capsule2017-06-220000-00-00NoNoCurrent