FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
60687-797
11-digit product format
606870797
Labeler code
60687
Product ID
60687-797_11e80915-df52-1580-e063-6394a90a67b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA074509
Marketing category
ANDA
Marketing start
2024-02-26
Substance
AMANTADINE HYDROCHLORIDE
Active strength
50 mg/5mL
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 HYDROCHLORIDE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM6Q1EO9TD0
Rxcui849385

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
60687-797-42Amantadine Hydrochloride10 mL in 1 CUP, UNIT-DOSESOLUTION101
60687-797-48Amantadine Hydrochloride10 in 1 TRAYSOLUTION101
60687-797-56Amantadine Hydrochloride10 in 1 CASESOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-797-42ML - Milliliter60687-797a3026f15-0ef2-4ae0-a6d6-7a9af732b19812024-05-16
60687-797-56ML - Milliliter60687-7972dd93659-3dbb-4c35-ace6-4438c023534a12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-797AMANTADINE HYDROCHLORIDE SOLUTION [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20240226_5a8f16cc-e5d5-4097-8297-10c8166c7a0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSN5a8f16cc-e5d5-4097-8297-10c8166c7a0e1
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCD5a8f16cc-e5d5-4097-8297-10c8166c7a0e1
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSY5a8f16cc-e5d5-4097-8297-10c8166c7a0e1
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSY5a8f16cc-e5d5-4097-8297-10c8166c7a0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-797-426068707974210 mL in 1 CUP, UNIT-DOSE10 mlHistorical
60687-797-486068707974810 in 1 TRAYHistorical
60687-797-566068707975610 TRAY in 1 CASE (60687-797-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-797-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-797-42) 10 tray2024-02-26NoNoCurrent