FDA.reportPublic FDA data

Amantadine Hydrochloride

Product NDC
60432-093
11-digit product format
604320093
Labeler code
60432
Product ID
60432-093_ccea7133-72cd-407f-813f-18a1107aba10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA075060
Marketing category
ANDA
Marketing start
1998-12-24
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60432-093-162025-11-14C16284748780-1f386c649-ef77-0266-e053-dadaa90a7c1ac446aed2-1add-4b09-9cc2-69ab95ae12d2
60432-093-162023-01-30C16284748780-1f386c649-ef77-0266-e053-dadaa90a7c1ac446aed2-1add-4b09-9cc2-69ab95ae12d2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-093-16ML - Milliliter60432-093f65efb65-7594-496b-bddf-4c9ce0d7810b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amantadine HydrochlorideACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]5
AmantadineACTIVE MOIETYBF4C9Z1J53AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]5
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLAMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]5
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TAMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]5
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]5
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHAMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]5
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYAMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]5
SorbitolINACTIVE INGREDIENT506T60A25RAMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]5
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KAMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]5
WaterINACTIVE INGREDIENT059QF0KO0RAMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]5
AMANTADINE HYDROCHLORIDEACTIVE INGREDIENTM6Q1EO9TD0AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
AMANTADINEACTIVE MOIETYBF4C9Z1J53AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPAMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RAMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAMANTADINE HYDROCHLORIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-093AMANTADINE HYDROCHLORIDE SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]6Legacy NDC20181222_c446aed2-1add-4b09-9cc2-69ab95ae12d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSN97d6bd4a-31ca-4b33-8353-a536835ef1e16
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCD97d6bd4a-31ca-4b33-8353-a536835ef1e16
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSY97d6bd4a-31ca-4b33-8353-a536835ef1e16
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSY97d6bd4a-31ca-4b33-8353-a536835ef1e16
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSN14452da8-3b48-497d-9017-bdfb967b7f561
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCD14452da8-3b48-497d-9017-bdfb967b7f561
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSY14452da8-3b48-497d-9017-bdfb967b7f561
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSY14452da8-3b48-497d-9017-bdfb967b7f561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-093-1660432009316473 mL in 1 BOTTLE, PLASTIC (60432-093-16) 473 ml1998-12-240000-00-00NoNoCurrent