FDA.reportPublic FDA data

NURTEC ODT

Product NDC
72618-3001
11-digit product format
726183001
Labeler code
72618
Product ID
72618-3001_8ca7820c-5f58-4958-998b-9e18481d7dc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rimegepant sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA212728
Marketing category
NDA
Marketing start
2020-03-05
Substance
RIMEGEPANT SULFATE
Active strength
75 mg/1
Pharmacologic classes
Calcitonin Gene-related Peptide Receptor Antagonist [EPC], Calcitonin Gene-related Peptide Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIMEGEPANT SULFATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1383NM3Q0H
Rxcui2282313, 2282320

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8be78f19-acf0-4ff5-9835-5b77f9de5644Product name120200626

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72618-3001-22024-01-30C16284748780-11030e365-1383-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NURTEC ® ODT safely and effectively. See full prescribing information for NURTEC ODT. NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use Initial U.S. Approval: 2020
72618-3001-22024-01-30C16284748780-11030e365-1383-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NURTEC ® ODT safely and effectively. See full prescribing information for NURTEC ODT. NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use Initial U.S. Approval: 2020
72618-3001-22024-01-30C16284748780-11030e365-1383-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NURTEC ® ODT safely and effectively. See full prescribing information for NURTEC ODT. NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use Initial U.S. Approval: 2020
72618-3001-22024-01-30C16284748780-11030e365-1383-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NURTEC ® ODT safely and effectively. See full prescribing information for NURTEC ODT. NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72618-3001-1NURTEC ODT2 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING231
72618-3001-1NURTEC ODT1 in 1 DOSE PACKTABLET, ORALLY DISINTEGRATING131
72618-3001-2NURTEC ODT4 in 1 CARTONTABLET, ORALLY DISINTEGRATING431

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72618-3001NURTEC ODT (RIMEGEPANT SULFATE) TABLET, ORALLY DISINTEGRATING [PFIZER LABORATORIES DIV PFIZER INC]25Current NDC, 3 package rows20250406_9ef08e09-1098-35cc-e053-2a95a90a3e1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2282320Nurtec ODT 75 MG Disintegrating Oral TabletPSN9ef08e09-1098-35cc-e053-2a95a90a3e1d31
2282313rimegepant 75 MG Disintegrating Oral TabletPSN9ef08e09-1098-35cc-e053-2a95a90a3e1d31
2282320rimegepant 75 MG Disintegrating Oral Tablet [Nurtec]SBD9ef08e09-1098-35cc-e053-2a95a90a3e1d31
2282313rimegepant 75 MG Disintegrating Oral TabletSCD9ef08e09-1098-35cc-e053-2a95a90a3e1d31
2282320Nurtec 75 MG Disintegrating Oral TabletSY9ef08e09-1098-35cc-e053-2a95a90a3e1d31
2282320Nurtec ODT 75 MG (as rimegepant sulfate 85.65 MG) Disintegrating Oral TabletSY9ef08e09-1098-35cc-e053-2a95a90a3e1d31
2282313rimegepant 75 MG (as rimegepant sulfate 85.65 MG) Disintegrating Oral TabletSY9ef08e09-1098-35cc-e053-2a95a90a3e1d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72618-3001-1726183001012 in 1 BLISTER PACKHistorical
72618-3001-2726183001024 DOSE PACK in 1 CARTON (72618-3001-2) / 1 BLISTER PACK in 1 DOSE PACK (72618-3001-1) / 2 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 dose pack2020-03-052028-06-30YesNoHistorical
72618-3001-4726183001041 BLISTER PACK in 1 CARTON (72618-3001-4) / 2 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2024-12-181Current