FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
39328-530
11-digit product format
393280530
Labeler code
39328
Product ID
39328-530_f923b293-f2ac-4116-a122-9524fe748aca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Patrin Pharma, Inc.
Application
ANDA214178
Marketing category
ANDA
Marketing start
2023-08-11
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39328-530-10Amantadine Hydrochloride10 mL in 1 CUP, UNIT-DOSESOLUTION103
39328-530-16Amantadine Hydrochloride473 mL in 1 BOTTLE, PLASTICSOLUTION4733
39328-530-99Amantadine Hydrochloride10 in 1 TRAYSOLUTION103
39328-530-99Amantadine Hydrochloride10 in 1 CASESOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-530-10ML - Milliliter39328-530cea7925c-4849-413d-b2ef-f6100dc88ab212024-04-05
39328-530-16ML - Milliliter39328-5301c3d61b6-78a0-4629-b85f-2bcd8e1b073512023-10-16
39328-530-99ML - Milliliter39328-530420f07b9-f843-4fc8-bd55-db374832739612024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-530AMANTADINE HYDROCHLORIDE SOLUTION [PATRIN PHARMA, INC.]3Current NDC, 4 package rows20240523_0fcf5182-a666-4f38-879f-47f19de30dd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSN0fcf5182-a666-4f38-879f-47f19de30dd53
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCD0fcf5182-a666-4f38-879f-47f19de30dd53
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSY0fcf5182-a666-4f38-879f-47f19de30dd53
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSY0fcf5182-a666-4f38-879f-47f19de30dd53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39328-530-103932805301010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
39328-530-1639328053016473 mL in 1 BOTTLE, PLASTIC (39328-530-16) 473 ml2023-08-11NoNoHistorical
39328-530-993932805309910 TRAY in 1 CASE (39328-530-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (39328-530-10) 10 tray2024-05-08NoNoHistorical