NURTEC ODT

Product NDC
85766-096
11-digit product format
857660096
Labeler code
85766
Product ID
85766-096_5031b9b1-0bd2-e9d8-e063-6394a90ac26e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rimegepant sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sportpharm LLC
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-096-08NURTEC ODT1 in 1 CARTONTABLET, ORALLY DISINTEGRATING12
85766-096-08NURTEC ODT8 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING82

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
85766-096-08857660096081 BLISTER PACK in 1 CARTON (85766-096-08) / 8 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2025-10-14NoNoCurrent