Adempas
- Product NDC
- 50419-254
- 11-digit product format
- 504190254
- Labeler code
- 50419
- Product ID
- 50419-254_d66cd275-ec90-4215-a5dc-ab622625fbd7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- riociguat
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA204819
- Marketing category
- NDA
- Marketing start
- 2013-10-08
- Substance
- RIOCIGUAT
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Guanylate Cyclase Stimulators [MoA], Soluble Guanylate Cyclase Stimulator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Adempas
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RIOCIGUAT | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RU3FE2Y4XI |
| Rxcui | 1439821, 1439823, 1439831, 1439833, 1439837, 1439894, 1439896, 1439899, 1439901, 1439903 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50419-254-01 | Adempas | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 29 |
| 50419-254-03 | Adempas | 2 in 1 PACKAGE | TABLET, FILM COATED | 2 | | 29 |
| 50419-254-03 | Adempas | 21 in 1 BLISTER PACK | TABLET, FILM COATED | 21 | | 29 |
| 50419-254-91 | Adempas | 9 in 1 BOTTLE | TABLET, FILM COATED | 9 | | 29 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RIOCIGUAT | ACTIVE INGREDIENT | RU3FE2Y4XI | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| RIOCIGUAT | ACTIVE MOIETY | RU3FE2Y4XI | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50419-254 | ADEMPAS (RIOCIGUAT) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 20 | Current NDC, Legacy NDC, 4 package rows | 20241106_7b57509a-3d5d-41d4-8fed-1471e26372a3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50419-254-01 | 50419025401 | 90 TABLET, FILM COATED in 1 BOTTLE (50419-254-01) | | 2013-10-08 | 0000-00-00 | No | No | Current |
| 50419-254-03 | 50419025403 | 2 BLISTER PACK in 1 PACKAGE (50419-254-03) / 21 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2013-10-08 | 0000-00-00 | No | No | Current |
| 50419-254-91 | 50419025491 | 9 TABLET, FILM COATED in 1 BOTTLE (50419-254-91) | | 2014-09-18 | 0000-00-00 | No | No | Current |