FDA.reportPublic FDA data

NDC 69616-211-04 - Firdapse

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69616-211
Requested NDC
69616-211-04
Package NDCs from labels
69616-211-04, 69616-211-06, 69616-211-08, 69616-211-03
Manufacturer
Catalyst Pharmaceuticals, Inc. | Catalent Micron Technologies, Inc. | Pharmaceutics International, Inc. | PCI Pharma Services Canada, Inc. | Quality Chemical Laboratories, LLC | Robertson-Microlit Laboratories Inc. | SGS Canada Inc. | SGS North America Inc.
Effective date
2026-04-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FirdapseCatalyst Pharmaceuticals, Inc. | Catalent Micron Technologies, Inc. | Pharmaceutics International, Inc. | PCI Pharma Services Canada, Inc. | Quality Chemical Laboratories, LLC | Robertson-Microlit Laboratories Inc. | SGS Canada Inc. | SGS North America Inc.2026-04-16HUMAN PRESCRIPTION DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 30 · 599 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pneumonia/Meningitis Nosode Combination 9414PNEUMONIA/MENINGITIS NOSODE COMBINATIONProfessional Complementary Health Formulas823de3e3-4d20-446c-988d-d7a70a747f9a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Childhood Immunization Detox 6032CHILDHOOD IMMUNIZATION DETOXProfessional Complementary Health Formulas4d455d07-3197-44d6-99d6-488fcdb50f952026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy Nosode 4017ALLERGY NOSODEProfessional Complementary Health Formulasda9145a5-42e9-4dba-9d11-195848e628a42026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Connective Tissue Liquescence 3024CONNECTIVE TISSUE LIQUESCENCEProfessional Complementary Health Formulasb7dab801-0256-40d7-8f66-7a0e7e76c3532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Childhood Vaccination Nosode Combination 9409CHILDHOOD VACCINATION NOSODE COMBINATIONProfessional Complementary Health Formulasa7a262f1-fe38-4e6b-aefa-f9e8a914f38e2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pleurisy Drops 2047PLEURISY DROPSProfessional Complementary Health Formulasb046d33f-170b-4b59-aa58-7632db9694fd2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Creosote Combination 9254CREOSOTE COMBINATIONProfessional Complementary Health Formulas9248c4d5-75a5-4b52-b6b1-b2b8af8da8272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bridged Ring Combination 9311BRIDGED RING COMBINATIONProfessional Complementary Health Formulasb4033f70-d974-493d-8ded-eaa3240bdac52026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Heart 7009RET HEARTProfessional Complementary Health Formulase2bf8331-1c50-4216-93a4-1d3cf64047592026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lumbar Drops 5013LUMBAR DROPSProfessional Complementary Health Formulasee6b54ea-fb6a-4723-8a0f-970aa82fea802026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Rehydration Drops 2175REHYDRATION DROPSProfessional Complementary Health Formulas58cc2bd1-c530-43bf-876e-f30d4d95b8da2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Dysfunctional Bleeding Drops 2138DYSFUNCTIONAL BLEEDING DROPSProfessional Complementary Health Formulas3e674c1e-c64b-416d-962f-c03493e800852026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Cervical Drops 5002CERVICAL DROPSProfessional Complementary Health Formulasedd5f196-1423-4d4c-a8c1-89427c4f387e2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Asbestox 6005ASBESTOXProfessional Complementary Health Formulas90bc0d00-01e4-4134-809e-e216fd09852a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Fourth Chakra (Heart) 7304FOURTH CHAKRA (HEART)Professional Complementary Health Formulasef061447-42ae-43d0-b6f3-bf19a96ffe922026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Spinal Drops 5025SPINAL DROPSProfessional Complementary Health Formulasca6d7250-9c9e-40a6-8d41-88aba33d21dd2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.