FDA.reportPublic FDA data

Rufinamide

Product NDC
72205-038
11-digit product format
722050038
Labeler code
72205
Product ID
72205-038_924ffdf9-ce5f-4989-9a43-78a03ba3eaed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rufinamide
Dosage form
SUSPENSION
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA214817
Marketing category
ANDA
Marketing start
2025-04-15
Substance
RUFINAMIDE
Active strength
40 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214817-001RUFINAMIDERUFINAMIDE40MG/MLSUSPENSION / ORALAB2025-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A214817-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214817-001RUFINAMIDE40MG/MLSUSPENSION / ORALAB2025-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214817-001RUFINAMIDE40MG/MLSUSPENSION / ORALAB2025-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A214817-001RUFINAMIDE40MG/MLSUSPENSION / ORALAB2025-04-156a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214817-001RUFINAMIDE40MG/MLSUSPENSION / ORALAB2025-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214817-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214817-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214817-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214817-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RUFINAMIDE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WFW942PR79Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1092357Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
924ffdf9-ce5f-4989-9a43-78a03ba3eaedAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
131b7904-af2d-e086-e6ed-019008086140Product name920260127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-038-77Rufinamide460 mL in 1 BOTTLESUSPENSION4601
72205-038-77Rufinamide1 in 1 CARTONSUSPENSION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-038-77ML - Milliliter72205-0389fdf2374-535e-473e-a805-31df28cd330b12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-038RUFINAMIDE SUSPENSION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 2 package rows20250423_924ffdf9-ce5f-4989-9a43-78a03ba3eaed.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RufinamideRUFINAMIDENovadoz Pharmaceuticals LLC924ffdf9-ce5f-4989-9a43-78a03ba3eaed2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214817
application number: ANDA214817
ndc (product): 72205-038

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092357rufinamide 40 MG in 1 mL Oral SuspensionPSN924ffdf9-ce5f-4989-9a43-78a03ba3eaed1
1092357rufinamide 40 MG/ML Oral SuspensionSCD924ffdf9-ce5f-4989-9a43-78a03ba3eaed1
1092357rufinamide 40 MG per 1 ML Oral SuspensionSY924ffdf9-ce5f-4989-9a43-78a03ba3eaed1
1092357rufinamide 400 MG per 10 ML Oral SuspensionSY924ffdf9-ce5f-4989-9a43-78a03ba3eaed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-038-77722050038771 BOTTLE in 1 CARTON (72205-038-77) / 460 mL in 1 BOTTLE1 bottle2025-06-01NoNoCurrent