FDA.reportPublic FDA data

Firdapse

Product NDC
69616-211
11-digit product format
696160211
Labeler code
69616
Product ID
69616-211_4f94edd2-b6a8-264d-e063-6294a90a89df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amifampridine phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Catalyst Pharmaceuticals, Inc.
Application
NDA208078
Marketing category
NDA
Marketing start
2019-01-07
Substance
AMIFAMPRIDINE PHOSPHATE
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
Firdapse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIFAMPRIDINE PHOSPHATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8HF8FIN815
Rxcui2106343, 2107518

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be5e1632-ea67-4526-852b-e88fa4d9ee01Product name120190802
ac48b7ac-cf50-4bcf-ac41-29203ef41712Product name120190124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69616-211-032020-07-22C16284748780-1ab0e2407-33f4-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018
69616-211-062020-07-22C16284748780-1ab0e2407-33f4-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018
69616-211-082020-07-22C16284748780-1ab0e2407-33f4-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69616-211-03Firdapse240 in 1 BOTTLE, PLASTICTABLET24015
69616-211-04Firdapse10 in 1 BLISTER PACKTABLET1015
69616-211-06Firdapse12 in 1 CARTONTABLET1215
69616-211-08Firdapse60 in 1 BOTTLE, PLASTICTABLET6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69616-211-03EA - Each69616-21120ad9e88-3723-411e-bd3b-1daa030a7a9612019-04-11
69616-211-04EA - Each69616-2115e9ad9a7-ece4-4e1c-8f53-24a48e2a5fdb12019-01-24
69616-211-06EA - Each69616-21117263468-4c6a-408e-8d77-25e99c3ec66712019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69616-211FIRDAPSE (AMIFAMPRIDINE PHOSPHATE) TABLET [CATALYST PHARMACEUTICALS, INC. ]14Current NDC, Legacy NDC, 4 package rows20240627_f015fe60-3128-4a43-8c31-19fc6b5def3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2106343amifampridine 10 MG Oral TabletPSNf015fe60-3128-4a43-8c31-19fc6b5def3f15
2107518Firdapse 10 MG Oral TabletPSNf015fe60-3128-4a43-8c31-19fc6b5def3f15
2107518amifampridine 10 MG Oral Tablet [Firdapse]SBDf015fe60-3128-4a43-8c31-19fc6b5def3f15
2106343amifampridine 10 MG Oral TabletSCDf015fe60-3128-4a43-8c31-19fc6b5def3f15
2106343amifampridine 10 MG (as amifampridine phosphate 18.98 MG) Oral TabletSYf015fe60-3128-4a43-8c31-19fc6b5def3f15
2107518Firdapse 10 MG (as amifampridine phosphate 18.98 MG) Oral TabletSYf015fe60-3128-4a43-8c31-19fc6b5def3f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69616-211-0369616021103240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03) 240 tablet2019-01-070000-00-00NoNoCurrent
69616-211-046961602110410 in 1 BLISTER PACKHistorical
69616-211-066961602110612 BLISTER PACK in 1 CARTON (69616-211-06) / 10 TABLET in 1 BLISTER PACK (69616-211-04) 12 blister pack2019-01-070000-00-00NoNoCurrent
69616-211-086961602110860 TABLET in 1 BOTTLE, PLASTIC (69616-211-08) 60 tablet2019-01-070000-00-00NoNoCurrent