FDA.reportPublic FDA data

PERAMPANEL

Product NDC
72205-071
11-digit product format
722050071
Labeler code
72205
Product ID
72205-071_4d8be129-f3cb-49ad-ae5a-a74a50dff689
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PERAMPANEL
Dosage form
SUSPENSION
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA218152
Marketing category
ANDA
Marketing start
2025-07-11
Substance
PERAMPANEL
Active strength
.5 mg/mL
Pharmacologic classes
AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]
DEA schedule
CIII
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
A218152-001PERAMPANELPERAMPANEL0.5MG/MLSUSPENSION / ORALAB2025-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218152-001AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A218152-001PC2026-06-14

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 UTC2026-02A218152-001PERAMPANEL0.5MG/MLSUSPENSION / ORALAB2025-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218152-001PERAMPANEL0.5MG/MLSUSPENSION / ORALAB2025-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218152-001PERAMPANEL0.5MG/MLSUSPENSION / ORALAB2025-07-116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218152-001PERAMPANEL0.5MG/MLSUSPENSION / ORALAB2025-07-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218152-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218152-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218152-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218152-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218152-001PC2026-06-14a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
PERAMPANEL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERAMPANEL.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H821664NPKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1790122Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d8be129-f3cb-49ad-ae5a-a74a50dff689Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
936a5710-8aab-7641-c7fe-d3c90f538696Product name320260306

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-071-79PERAMPANEL340 mL in 1 BOTTLESUSPENSION3401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-071-79ML - Milliliter72205-0714ee1eb5e-3ce1-4374-8c05-7187a824fa7412026-01-08

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
PERAMPANELPERAMPANELNovadoz Pharmaceuticals LLC4d8be129-f3cb-49ad-ae5a-a74a50dff6892022-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218152
application number: ANDA218152
ndc (product): 72205-071

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790122perampanel 0.5 MG in 1 mL Oral SuspensionPSN4d8be129-f3cb-49ad-ae5a-a74a50dff6891
1790122perampanel 0.5 MG/ML Oral SuspensionSCD4d8be129-f3cb-49ad-ae5a-a74a50dff6891
1790122perampanel 0.5 MG per 1 ML Oral SuspensionSY4d8be129-f3cb-49ad-ae5a-a74a50dff6891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-071-7972205007179340 mL in 1 BOTTLE (72205-071-79) 340 ml2025-12-15NoNoCurrent