RYBELSUS
- Product NDC
- 0169-4307
- 11-digit product format
- 001694307
- Labeler code
- 0169
- Product ID
- 0169-4307_5176eed4-f8f8-4f88-a079-11f16864f40a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oral semaglutide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novo Nordisk Pharmaceutical Industries, LP
- Application
- NDA213051
- Marketing category
- NDA
- Marketing start
- 2019-09-20
- Substance
- SEMAGLUTIDE
- Active strength
- 7 mg/1
- Pharmacologic classes
- GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RYBELSUS
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SEMAGLUTIDE | 7 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 53AXN4NNHX |
| Rxcui | 2200644, 2200650, 2200652, 2200654, 2200656, 2200658, 2707547, 2707549, 2707551, 2707553, 2707555, 2707557, 2736944, 2736946, 2736948 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0169-4307-01 | RYBELSUS | 10 in 1 BLISTER PACK | TABLET | 10 | | 13 |
| 0169-4307-13 | RYBELSUS | 3 in 1 CARTON | TABLET | 3 | | 13 |
| 0169-4307-30 | RYBELSUS | 30 in 1 BOTTLE, GLASS | TABLET | 30 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0169-4307 | RYBELSUS (ORAL SEMAGLUTIDE) TABLET [NOVO NORDISK] | 10 | Current NDC, Legacy NDC, 3 package rows | 20241225_27f15fac-7d98-4114-a2ec-92494a91da98.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0169-4307-01 | 00169430701 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 0169-4307-13 | 00169430713 | 3 BLISTER PACK in 1 CARTON (0169-4307-13) > 10 TABLET in 1 BLISTER PACK (0169-4307-01) | 3 blister pack | 2019-09-20 | 0000-00-00 | No | No | Current |
| 0169-4307-30 | 00169430730 | 30 TABLET in 1 BOTTLE, GLASS (0169-4307-30) | 30 tablet | 2021-10-04 | 0000-00-00 | No | No | Current |