NDC 54092-547
MOTEGRITY
Prucalopride
MOTEGRITY is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Prucalopride Succinate.
| Product ID | 54092-547_36754500-401c-4066-8582-79d1261be5d8 |
| NDC | 54092-547 |
| Product Type | Human Prescription Drug |
| Proprietary Name | MOTEGRITY |
| Generic Name | Prucalopride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-12-14 |
| Marketing Category | NDA / NDA |
| Application Number | NDA210166 |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Substance Name | PRUCALOPRIDE SUCCINATE |
| Active Ingredient Strength | 2 mg/1 |
| Pharm Classes | Serotonin-4 Receptor Agonist [EPC],Serotonin 4 Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 54092-547-01
30 TABLET, FILM COATED in 1 BOTTLE (54092-547-01)
| Marketing Start Date | 2018-12-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 54092-547-02 [54092054702]
MOTEGRITY TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA210166 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-12-14 |
NDC 54092-547-01 [54092054701]
MOTEGRITY TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA210166 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-12-14 |
NDC 54092-547-03 [54092054703]
MOTEGRITY TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA210166 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-12-14 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PRUCALOPRIDE SUCCINATE | 2 mg/1 |
OpenFDA Data
| SPL SET ID: | bca1e4c6-4b2b-4876-8ab3-654629c4ff1b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "MOTEGRITY" or generic name "Prucalopride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 54092-546 | MOTEGRITY | PRUCALOPRIDE |
| 54092-547 | MOTEGRITY | PRUCALOPRIDE |
Trademark Results [MOTEGRITY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOTEGRITY 87673187 5776458 Live/Registered |
Shire LLC 2017-11-06 |
 MOTEGRITY 87329871 5794940 Live/Registered |
Shire LLC 2017-02-09 |
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