Amantadine HCl

Product NDC
21695-564
11-digit product format
216950564
Labeler code
21695
Product ID
21695-564_c74c9424-278d-4a52-8866-db66f6c3ac67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA078720
Marketing category
ANDA
Marketing start
2008-11-01
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
E
Listing certified through
2017-12-31
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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-564-102019-09-24C16284748780-1934fe258-4b12-48b1-e053-8cdaa90a720ac74c9424-278d-4a52-8866-db66f6c3ac67

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-564-10Amantadine HCl10 in 1 BOTTLECAPSULE101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-564-10EA - Each21695-5647de46e40-3848-4ef0-8ea4-1b0b5cd0a94c12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-564AMANTADINE HCL (AMANTADINE HYDROCHLORIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20101210_c74c9424-278d-4a52-8866-db66f6c3ac67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849389amantadine HCl 100 MG Oral CapsulePSNc74c9424-278d-4a52-8866-db66f6c3ac671
849389amantadine hydrochloride 100 MG Oral CapsuleSCDc74c9424-278d-4a52-8866-db66f6c3ac671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-564-102169505641010 in 1 BOTTLEHistorical