FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
62135-011
11-digit product format
621350011
Labeler code
62135
Product ID
62135-011_45c62a1b-f162-d3cb-e063-6394a90a7dbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA074028
Marketing category
ANDA
Marketing start
1993-06-28
Substance
AMANTADINE HYDROCHLORIDE
Active strength
100 mg/10mL
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/10mL

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
62135-011-24Amantadine Hydrochloride10 in 1 TRAYSOLUTION105
62135-011-24Amantadine Hydrochloride2 in 1 BOXSOLUTION25
62135-011-59Amantadine Hydrochloride10 mL in 1 CUP, UNIT-DOSESOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-011AMANTADINE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC]4Current NDC, 3 package rows20240524_52aa093c-82cc-4d81-b072-86a2b8adc9c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSN52aa093c-82cc-4d81-b072-86a2b8adc9c55
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCD52aa093c-82cc-4d81-b072-86a2b8adc9c55
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSY52aa093c-82cc-4d81-b072-86a2b8adc9c55
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSY52aa093c-82cc-4d81-b072-86a2b8adc9c55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-011-24621350011242 TRAY in 1 BOX (62135-011-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (62135-011-59) 2 tray1993-06-28NoNoCurrent
62135-011-596213500115910 mL in 1 CUP, UNIT-DOSE10 mlHistorical