FDA.reportPublic FDA data

Amantadine

Product NDC
0116-4010
11-digit product format
001164010
Labeler code
0116
Product ID
0116-4010_3479947d-22a8-67e8-e063-6294a90ae41c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine
Dosage form
SOLUTION
Route
ORAL
Labeler
Xttrium Laboratories, Inc
Application
ANDA075060
Marketing category
ANDA
Marketing start
2024-11-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amantadine
Listing expiration
2027-12-31

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721Product name220220224
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0116-4010-10Amantadine10 mL in 1 CUP, UNIT-DOSESOLUTION102
0116-4010-16Amantadine473 mL in 1 BOTTLESOLUTION4732
0116-4010-41Amantadine10 in 1 TRAYSOLUTION102
0116-4010-41Amantadine100 in 1 CASESOLUTION1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0116-4010-10ML - Milliliter0116-40104f6689fa-38ad-41f0-b0e7-42a20aed150412025-07-08
0116-4010-16ML - Milliliter0116-40105125b5ac-bbac-402e-8ed3-8d718552ef1b12025-02-10
0116-4010-41ML - Milliliter0116-4010f520c126-fec1-4545-b0af-29db845b4cb412025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-4010AMANTADINE SOLUTION [XTTRIUM LABORATORIES, INC]1Current NDC, 4 package rows20241106_25dd8a3c-6b11-2ea1-e063-6294a90a50cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849385amantadine HCl 50 MG in 5 mL Oral SolutionPSN25dd8a3c-6b11-2ea1-e063-6294a90a50cf2
849385amantadine hydrochloride 10 MG/ML Oral SolutionSCD25dd8a3c-6b11-2ea1-e063-6294a90a50cf2
849385amantadine hydrochloride 100 MG per 10 ML Oral SolutionSY25dd8a3c-6b11-2ea1-e063-6294a90a50cf2
849385amantadine hydrochloride 50 MG per 5 ML Oral SolutionSY25dd8a3c-6b11-2ea1-e063-6294a90a50cf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0116-4010-100011640101010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
0116-4010-1600116401016473 mL in 1 BOTTLE (0116-4010-16) 473 ml2024-11-05NoNoHistorical
0116-4010-4100116401041100 TRAY in 1 CASE (0116-4010-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4010-10) 100 tray2024-11-05NoNoHistorical