FDA.reportPublic FDA data

AMANTADINE HYDROCHLORIDE

Product NDC
17856-0646
11-digit product format
178560646
Labeler code
17856
Product ID
17856-0646_34f3552c-a90d-da9a-e063-6294a90a65a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMANTADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA074509
Marketing category
ANDA
Marketing start
1995-07-17
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0646-12024-04-08C16284748780-11030e365-34fe-111a-e063-dadaa90a10e2Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL
17856-0646-22024-04-08C16284748780-11030e365-34fe-111a-e063-dadaa90a10e2Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL
17856-0646-12024-01-30C16284748780-11030e365-34fe-111a-e063-dadaa90a10e2Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL
17856-0646-22024-01-30C16284748780-11030e365-34fe-111a-e063-dadaa90a10e2Amantadine Hydrochloride Oral Solution USP 50 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0646-1AMANTADINE HYDROCHLORIDE72 in 1 BOX, UNIT-DOSESOLUTION724
17856-0646-2AMANTADINE HYDROCHLORIDE72 in 1 PACKAGESOLUTION724
17856-0646-3AMANTADINE HYDROCHLORIDE10 mL in 1 CUP, UNIT-DOSESOLUTION104
17856-0646-4AMANTADINE HYDROCHLORIDE5 mL in 1 CUP, UNIT-DOSESOLUTION54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0646-1ML - Milliliter17856-0646131fab16-c40f-4017-b8e6-0450c9c3649f12025-06-13
17856-0646-2ML - Milliliter17856-06460f48881a-f29b-4b66-bb38-0ccada9cb37c12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0646AMANTADINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Current NDC, Legacy NDC, 4 package rows20250514_6311b46b-23cc-40c1-93c2-f7c92606386f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSN6311b46b-23cc-40c1-93c2-f7c92606386f4
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCD6311b46b-23cc-40c1-93c2-f7c92606386f4
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSY6311b46b-23cc-40c1-93c2-f7c92606386f4
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSY6311b46b-23cc-40c1-93c2-f7c92606386f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0646-11785606460172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0646-1) / 10 mL in 1 CUP, UNIT-DOSE (17856-0646-3) 2024-04-080000-00-00NoNoCurrent
17856-0646-21785606460272 CUP, UNIT-DOSE in 1 PACKAGE (17856-0646-2) / 5 mL in 1 CUP, UNIT-DOSE (17856-0646-4) 2024-04-080000-00-00NoNoCurrent
17856-0646-31785606460310 mL in 1 CUP, UNIT-DOSE10 mlHistorical
17856-0646-4178560646045 mL in 1 CUP, UNIT-DOSE5 mlHistorical