NDC 0169-4303
RYBELSUS
Oral Semaglutide
RYBELSUS is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novo Nordisk. The primary component is Semaglutide.
| Product ID | 0169-4303_27f15fac-7d98-4114-a2ec-92494a91da98 |
| NDC | 0169-4303 |
| Product Type | Human Prescription Drug |
| Proprietary Name | RYBELSUS |
| Generic Name | Oral Semaglutide |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-09-20 |
| Marketing Category | NDA / NDA |
| Application Number | NDA213051 |
| Labeler Name | Novo Nordisk |
| Substance Name | SEMAGLUTIDE |
| Active Ingredient Strength | 3 mg/1 |
| Pharm Classes | GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0169-4303-13
3 BLISTER PACK in 1 CARTON (0169-4303-13) > 10 TABLET in 1 BLISTER PACK (0169-4303-01)
| Marketing Start Date | 2019-09-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0169-4303-93 [00169430393]
RYBELSUS TABLET
| Marketing Category | NDA |
| Application Number | NDA213051 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-09-20 |
NDC 0169-4303-13 [00169430313]
RYBELSUS TABLET
| Marketing Category | NDA |
| Application Number | NDA213051 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-09-20 |
NDC 0169-4303-01 [00169430301]
RYBELSUS TABLET
| Marketing Category | NDA |
| Application Number | NDA213051 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-09-20 |
NDC 0169-4303-90 [00169430390]
RYBELSUS TABLET
| Marketing Category | NDA |
| Application Number | NDA213051 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-09-20 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SEMAGLUTIDE | 3 mg/1 |
OpenFDA Data
| SPL SET ID: | 27f15fac-7d98-4114-a2ec-92494a91da98 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- GLP-1 Receptor Agonist [EPC]
- Glucagon-Like Peptide 1 [CS]
- Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC Crossover Matching brand name "RYBELSUS" or generic name "Oral Semaglutide"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0169-4303 | RYBELSUS | Oral Semaglutide |
| 0169-4307 | RYBELSUS | Oral Semaglutide |
| 0169-4314 | RYBELSUS | Oral Semaglutide |
Trademark Results [RYBELSUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RYBELSUS 79242284 5682853 Live/Registered |
Novo Nordisk A/S 2018-07-09 |
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