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
openFDA Listing Details
- Product ID
- 72618-3001_8ca7820c-5f58-4958-998b-9e18481d7dc0
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- NURTEC ODT
- Generic name
- rimegepant sulfate
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Marketing start
- 2020-03-05
- Marketing category
- NDA
- Application number
- NDA212728
- Pharmacologic classes
- Calcitonin Gene-related Peptide Receptor Antagonist [EPC]; Calcitonin Gene-related Peptide Receptor Antagonists [MoA]
- Listing expiration
- 2027-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| RIMEGEPANT SULFATE | 75 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 1383NM3Q0H |
| Rxcui | 2282313, 2282320 |
| Spl Set Id | 9ef08e09-1098-35cc-e053-2a95a90a3e1d |
| Manufacturer Name | Pfizer Laboratories Div Pfizer Inc |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 1383NM3Q0H | RIMEGEPANT SULFATE | 1374024-48-2 | RIMEGEPANT SULFATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72618-3001-2 | 72618300102 | 4 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 PACK | 4 dose pack | 2020-03-05 | Yes | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| NURTEC ODT | Pfizer Laboratories Div Pfizer Inc | 2026-04-21 | HUMAN PRESCRIPTION DRUG LABEL | 31 |