FDA.reportPublic FDA data

NURTEC ODT

Product NDC
72618-3000
11-digit product format
726183000
Labeler code
72618
Product ID
72618-3000_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
72618-3000-22024-01-30C16284748780-11030e365-1383-111a-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
72618-3000-22024-01-30C16284748780-11030e365-1383-111a-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
72618-3000-22024-01-30C16284748780-11030e365-1383-111a-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
72618-3000-22024-01-30C16284748780-11030e365-1383-111a-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
72618-3000-2NURTEC ODT1 in 1 CARTONTABLET, ORALLY DISINTEGRATING131
72618-3000-2NURTEC ODT8 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING831

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72618-3000-2EA - Each72618-30001a6a84ce-ffe3-4ed1-997b-ca97ef946c8912020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72618-3000NURTEC ODT (RIMEGEPANT SULFATE) TABLET, ORALLY DISINTEGRATING [PFIZER LABORATORIES DIV PFIZER INC]25Current NDC, Legacy NDC, 2 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
2282320Nurtec ODT 75 MG Disintegrating Oral TabletPSN86ef19d2-d6dc-4ac1-a793-dc549cc6bb9b2
2282313rimegepant 75 MG Disintegrating Oral TabletPSN86ef19d2-d6dc-4ac1-a793-dc549cc6bb9b2
2282320rimegepant 75 MG Disintegrating Oral Tablet [Nurtec]SBD86ef19d2-d6dc-4ac1-a793-dc549cc6bb9b2
2282313rimegepant 75 MG Disintegrating Oral TabletSCD86ef19d2-d6dc-4ac1-a793-dc549cc6bb9b2
2282320Nurtec 75 MG Disintegrating Oral TabletSY86ef19d2-d6dc-4ac1-a793-dc549cc6bb9b2
2282320Nurtec ODT 75 MG (as rimegepant sulfate 85.65 MG) Disintegrating Oral TabletSY86ef19d2-d6dc-4ac1-a793-dc549cc6bb9b2
2282313rimegepant 75 MG (as rimegepant sulfate 85.65 MG) Disintegrating Oral TabletSY86ef19d2-d6dc-4ac1-a793-dc549cc6bb9b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72618-3000-2726183000021 BLISTER PACK in 1 CARTON (72618-3000-2) / 8 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2020-03-050000-00-00NoNoCurrent