Prescription drug · NDA
Adempas (Riociguat) NDC 50419-254
Riociguat 2.5 mg/1 · Tablet, Film coated · Oral · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-254-01 | 50419025401 | 90 TABLET, FILM COATED in 1 BOTTLE (50419-254-01)Marketed from Oct 8, 2013 | |
| 50419-254-03 | 50419025403 | 2 BLISTER PACK in 1 PACKAGE (50419-254-03) / 21 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 8, 2013 | |
| 50419-254-91 | 50419025491 | 9 TABLET, FILM COATED in 1 BOTTLE (50419-254-91)Marketed from Sep 18, 2014 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Adempas
- Generic name (nonproprietary)
- riociguat
- Active ingredients
- Riociguat — 2.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204819
- Marketing start
- Listing expires
- Other FDA classes
- Guanylate Cyclase Stimulators (Mechanism)
- Identifiers
- Product ID 50419-254_21ffd9c9-204f-4809-af50-5e6f26e9d4ceSPL ID 21ffd9c9-204f-4809-af50-5e6f26e9d4ceSPL set ID 7b57509a-3d5d-41d4-8fed-1471e26372a3RxCUI 1439821, 1439823, 1439831, 1439833, 1439837, 1439894, 1439896, 1439899, 1439901, 1439903UNII RU3FE2Y4XI
- Pharmacologic class
- Soluble Guanylate Cyclase Stimulator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450419025401followed by a unit qualifier and the quantityPackage 50419-0254-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Adempas is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of adults with: • Persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class. ( 1.1 ) • Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening. ( 1.2 ) 1.1 Chronic-Thromboembolic Pulmonary Hypertension Adempas is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to imp…
Excerpt only. Read the full label for complete information.
About NDC 50419-254
- What is NDC 50419-254?
- 50419-254 is the product NDC for Adempas (riociguat), Riociguat 2.5 mg/1 tablet, film coated, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Adempas (Riociguat).
- What is the active ingredient?
- Riociguat.
- Who is the labeler?
- Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Adempas?
- 4 other product NDCs are listed under this name. See all Adempas NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Adempas products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Adempasriociguat | Riociguat 1.5 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-252 | 50419-0252-0150419-0252-0350419-0252-91 |
| Adempasriociguat | Riociguat .5 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-250 | 50419-0250-0150419-0250-0350419-0250-71+1 more |
| Adempasriociguat | Riociguat 1 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-251 | 50419-0251-0150419-0251-0350419-0251-71+1 more |
| Adempasriociguat | Riociguat 2 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-253 | 50419-0253-0150419-0253-0350419-0253-91 |
Other NDCs under NDA 204819
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Adempasriociguat | Riociguat 1.5 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-252 |
| Adempasriociguat | Riociguat .5 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-250 |
| Adempasriociguat | Riociguat 1 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-251 |
| Adempasriociguat | Riociguat 2 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-253 |