FDA.reportPublic FDA data

AMANTADINE HYDROCHLORIDE

Product NDC
0121-0646
11-digit product format
001210646
Labeler code
0121
Product ID
0121-0646_0d5911e6-e5b6-4013-98ec-773d9ec62dec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMANTADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0646-10AMANTADINE HYDROCHLORIDE10 in 1 CASESOLUTION1011
0121-0646-10AMANTADINE HYDROCHLORIDE10 in 1 TRAYSOLUTION1011
0121-0646-16AMANTADINE HYDROCHLORIDE473 mL in 1 BOTTLESOLUTION47311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0646-10ML - Milliliter0121-0646656e7c2c-f161-4450-8331-b56526061cbd12013-02-13
0121-0646-16ML - Milliliter0121-0646a7f35917-f53e-406d-8c7e-94f9c2ef515e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMANTADINE HYDROCHLORIDEACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
AMANTADINEACTIVE MOIETYBF4C9Z1J53AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RAMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RAMANTADINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
AMANTADINE HYDROCHLORIDEACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
AMANTADINEACTIVE MOIETYBF4C9Z1J53AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
SORBITOLINACTIVE INGREDIENT506T60A25RAMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2
WATERINACTIVE INGREDIENT059QF0KO0RAMANTADINE HYDROCHLORIDE SOLUTION [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0646AMANTADINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]10Current NDC, Legacy NDC, 3 package rows20241114_be411327-5ac7-46df-b5e4-32a11b419b15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSNbe411327-5ac7-46df-b5e4-32a11b419b1511
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCDbe411327-5ac7-46df-b5e4-32a11b419b1511
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSYbe411327-5ac7-46df-b5e4-32a11b419b1511
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSYbe411327-5ac7-46df-b5e4-32a11b419b1511
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSN5989098d-2855-4b5f-9a06-64a83656c07810
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCD5989098d-2855-4b5f-9a06-64a83656c07810
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSY5989098d-2855-4b5f-9a06-64a83656c07810
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSY5989098d-2855-4b5f-9a06-64a83656c07810
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSNe62c3ce4-af0a-4e5e-82ab-c74fd65449ac4
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSN6311b46b-23cc-40c1-93c2-f7c92606386f4
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCDe62c3ce4-af0a-4e5e-82ab-c74fd65449ac4
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCD6311b46b-23cc-40c1-93c2-f7c92606386f4
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSYe62c3ce4-af0a-4e5e-82ab-c74fd65449ac4
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSY6311b46b-23cc-40c1-93c2-f7c92606386f4
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSYe62c3ce4-af0a-4e5e-82ab-c74fd65449ac4
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSY6311b46b-23cc-40c1-93c2-f7c92606386f4
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSN908787d6-159f-486e-a4bb-5d55c14f5c322
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCD908787d6-159f-486e-a4bb-5d55c14f5c322
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSY908787d6-159f-486e-a4bb-5d55c14f5c322
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSY908787d6-159f-486e-a4bb-5d55c14f5c322
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 startMarketing endSampleExclude flagStatus
0121-0646-100012106461010 TRAY in 1 CASE (0121-0646-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE10 tray1995-07-170000-00-00NoNoCurrent
0121-0646-1600121064616473 mL in 1 BOTTLE (0121-0646-16) 473 ml1995-07-170000-00-00NoNoCurrent