FDA.reportPublic FDA data

AMPYRA

Product NDC
10144-427
11-digit product format
101440427
Labeler code
10144
Product ID
10144-427_dda9045d-2f23-412c-9543-74832f421739
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dalfampridine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Merz Pharmaceuticals, LLC
Application
NDA022250
Marketing category
NDA
Marketing start
2010-03-01
Substance
DALFAMPRIDINE
Active strength
10 mg/1
Pharmacologic classes
Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DALFAMPRIDINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBH3B64OKL9
Rxcui897021, 897025

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9109832c-cb3c-b72f-db80-0e6688f08431Product name520190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10144-427-60AMPYRA60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10144-427-60EA - Each10144-427efcd7340-55b3-4f6f-a82f-d4690ba04aa512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DALFAMPRIDINEACTIVE INGREDIENTBH3B64OKL9AMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [ACORDA THERAPEUTICS, INC.]8
DALFAMPRIDINEACTIVE MOIETYBH3B64OKL9AMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [ACORDA THERAPEUTICS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [ACORDA THERAPEUTICS, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [ACORDA THERAPEUTICS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [ACORDA THERAPEUTICS, INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [ACORDA THERAPEUTICS, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [ACORDA THERAPEUTICS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [ACORDA THERAPEUTICS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10144-427AMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [MERZ PHARMACEUTICALS, LLC]21Current NDC, Legacy NDC, 1 package rows20241222_550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897025Ampyra 10 MG 12HR Extended Release Oral TabletPSN550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
897021dalfampridine 10 MG 12HR Extended Release Oral TabletPSN550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
89702512 HR dalfampridine 10 MG Extended Release Oral Tablet [Ampyra]SBD550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
89702112 HR dalfampridine 10 MG Extended Release Oral TabletSCD550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
89702512 HR Ampyra 10 MG Extended Release Oral TabletSY550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
897025Ampyra 10 MG 12 HR Extended Release Oral TabletSY550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
897021dalfampridine 10 MG 12 HR Extended Release Oral TabletSY550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10144-427-601014404276060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10144-427-60) 2010-03-010000-00-00NoNoCurrent