FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
0904-7042
11-digit product format
009047042
Labeler code
0904
Product ID
0904-7042_e997ef48-cfa3-4aa8-bbea-be54c4c00f64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA209171
Marketing category
ANDA
Marketing start
2017-06-12
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

Additional Listing Data#

Finished product
Yes
Brand name base
Amantadine Hydrochloride
Listing expiration
2027-12-31

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
0904-7042-06Amantadine Hydrochloride50 in 1 CARTONCAPSULE509
0904-7042-06Amantadine Hydrochloride1 in 1 BLISTER PACKCAPSULE19
0904-7042-40Amantadine Hydrochloride500 in 1 BOTTLECAPSULE5009
0904-7042-59Amantadine Hydrochloride100 in 1 BOTTLECAPSULE1009
0904-7042-61Amantadine Hydrochloride100 in 1 CARTONCAPSULE1009
0904-7042-61Amantadine Hydrochloride1 in 1 BLISTER PACKCAPSULE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7042-40EA - Each0904-7042b6b57089-c433-4143-91fb-b627f68fd61312020-06-05
0904-7042-59EA - Each0904-70423b56776e-1573-4145-acb4-108f2782cfee12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7042AMANTADINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]7Current NDC, Legacy NDC, 6 package rows20250426_b2f7da34-ad78-4db3-9af1-bdd341e09f16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSNb2f7da34-ad78-4db3-9af1-bdd341e09f169
849389amantadine hydrochloride 100 MG Oral CapsuleSCDb2f7da34-ad78-4db3-9af1-bdd341e09f169

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7042-060090470420650 BLISTER PACK in 1 CARTON (0904-7042-06) / 1 CAPSULE in 1 BLISTER PACK50 blister pack2017-06-120000-00-00NoNoCurrent
0904-7042-4000904704240500 CAPSULE in 1 BOTTLE (0904-7042-40) 500 capsule2017-06-120000-00-00NoNoCurrent
0904-7042-5900904704259100 CAPSULE in 1 BOTTLE (0904-7042-59) 100 capsule2017-06-120000-00-00NoNoCurrent
0904-7042-6100904704261100 BLISTER PACK in 1 CARTON (0904-7042-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2017-06-120000-00-00NoNoCurrent