Xadago
- Product NDC
- 27505-111
- 11-digit product format
- 275050111
- Labeler code
- 27505
- Product ID
- 27505-111_41c1c50d-7460-15f0-e063-6294a90a1b79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- safinamide mesylate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.
- Application
- NDA207145
- Marketing category
- NDA
- Marketing start
- 2017-05-08
- Substance
- SAFINAMIDE MESYLATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Monoamine Oxidase Type B Inhibitor [EPC], Monoamine Oxidase-B Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xadago
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SAFINAMIDE MESYLATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YS90V3DTX0 |
| Rxcui | 1922466, 1922472, 1922474, 1922476 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27505-111-14 | Xadago | 14 in 1 BLISTER PACK | TABLET, FILM COATED | 14 | | 20 |
| 27505-111-14 | Xadago | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 20 |
| 27505-111-30 | Xadago | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 20 |
| 27505-111-30 | Xadago | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 20 |
| 27505-111-90 | Xadago | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 20 |
| 27505-111-90 | Xadago | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27505-111 | XADAGO (SAFINAMIDE MESYLATE) TABLET, FILM COATED [MDD US OPERATIONS LLC, A SUBSIDIARY OF SUPERNUS PHARMACEUTICALS, INC.] | 17 | Current NDC, Legacy NDC, 6 package rows | 20241012_c4d65f28-983f-42b4-bb23-023ae0fe81b2.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 |
|---|
| 27505-111-14 | 27505011114 | 1 BLISTER PACK in 1 CARTON (27505-111-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2017-05-08 | 0000-00-00 | No | No | Current |
| 27505-111-30 | 27505011130 | 1 BOTTLE in 1 CARTON (27505-111-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2017-05-08 | 0000-00-00 | No | No | Current |
| 27505-111-90 | 27505011190 | 1 BOTTLE in 1 CARTON (27505-111-90) / 90 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2017-05-08 | 0000-00-00 | No | No | Current |