FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
10135-693
11-digit product format
101350693
Labeler code
10135
Product ID
10135-693_3e752827-026e-d525-e063-6394a90a7e80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA210129
Marketing category
ANDA
Marketing start
2020-03-01
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, 849395

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
10135-693-01Amantadine Hydrochloride100 in 1 BOTTLECAPSULE, GELATIN COATED1008
10135-693-05Amantadine Hydrochloride500 in 1 BOTTLECAPSULE, GELATIN COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-693-01EA - Each10135-6935f792b15-e7fa-4bb1-ab7b-b89805b4923812020-04-20
10135-693-05EA - Each10135-6931179d386-50be-472c-9a34-3082b2a3f50612020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-693AMANTADINE HYDROCHLORIDE TABLET AMANTADINE HYDROCHLORIDE CAPSULE, GELATIN COATED [MARLEX PHARMACEUTICALS INC]7Current NDC, Legacy NDC, 2 package rows20241025_25af52ee-9b29-4c07-a383-62d4537b63e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSN25af52ee-9b29-4c07-a383-62d4537b63e08
849395amantadine HCl 100 MG Oral TabletPSN25af52ee-9b29-4c07-a383-62d4537b63e08
849389amantadine hydrochloride 100 MG Oral CapsuleSCD25af52ee-9b29-4c07-a383-62d4537b63e08
849395amantadine hydrochloride 100 MG Oral TabletSCD25af52ee-9b29-4c07-a383-62d4537b63e08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10135-693-0110135069301100 CAPSULE, GELATIN COATED in 1 BOTTLE (10135-693-01) 2020-03-010000-00-00NoNoCurrent
10135-693-0510135069305500 CAPSULE, GELATIN COATED in 1 BOTTLE (10135-693-05) 2020-03-010000-00-00NoNoCurrent