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riociguat
ANDA TE AB
Informational index, not medical advice. Content is reproduced from
public FDA and NLM data. Always confirm against the manufacturer's current
prescribing information. Report adverse events to FDA MedWatch.
Overview
Brand name
Riociguat
Generic name
riociguat
Dosage form
Tablet, Film Coated
Route
—
Marketing category
DRUG FOR FURTHER PROCESSING · BULK API
Labeler
Bayer AG
Product type
Drug For Further Processing
DEA schedule
Not scheduled
Active ingredients
5
NDC product codes
15
Packages
20
Data completeness
60%
of corroborating sources present
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryDosage form
Tablet, Film Coated
Route of administration
—
Presentations
35
Pharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Guanylate Cyclase Stimulators [MoA] | MoA | 3 members — no class page |
| Soluble Guanylate Cyclase Stimulator [EPC] | EPC | 3 members — no class page |
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
211135
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 1, 2022
Sponsor
MSN
Products on application
5
Submissions recorded
3
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 211135-001 | RIOCIGUAT | TABLET | RIOCIGUAT | Prescription | AB | ||
| 211135-002 | RIOCIGUAT | TABLET | RIOCIGUAT | Prescription | AB | ||
| 211135-003 | RIOCIGUAT | TABLET | RIOCIGUAT | Prescription | AB | ||
| 211135-004 | RIOCIGUAT | TABLET | RIOCIGUAT | Prescription | AB | ||
| 211135-005 | RIOCIGUAT | TABLET | RIOCIGUAT | Prescription | AB |
Therapeutic equivalence
Source: Orange BookTE code
AB
Reference Listed Drug
No
Reference Standard
No
What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 2 | REMS | Approved | August 4, 2026 | — |
| Supplement | 1 | REMS | Approved | May 8, 2026 | — |
| Original application | 1 | Approved | September 1, 2022 | Standard |
Adverse event reports
Source: openFDA FAERS32,415
FAERS reports mentioning this drug
A report count is not a risk measure. FAERS accepts voluntary and
mandatory reports without establishing causation, and reporting is influenced by how
widely a drug is used, how long it has been marketed, and media attention. FDA states
that reports “do not prove that the drug caused the event”. Compare rates, not totals.
Attributed to this product's most-reported active ingredient: RIOCIGUAT. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 12527-0250-9 | 12527-0250 | Bayer AG | 342857 TABLET, FILM COATED in 1 DRUM (12527-0250-9) | September 1, 2018 |
| 12527-0251-9 | 12527-0251 | Bayer AG | 342857 TABLET, FILM COATED in 1 DRUM (12527-0251-9) | September 1, 2018 |
| 12527-0252-9 | 12527-0252 | Bayer AG | 342857 TABLET, FILM COATED in 1 DRUM (12527-0252-9) | September 1, 2018 |
| 12527-0253-9 | 12527-0253 | Bayer AG | 342857 TABLET, FILM COATED in 1 DRUM (12527-0253-9) | September 1, 2018 |
| 12527-0254-9 | 12527-0254 | Bayer AG | 342857 TABLET, FILM COATED in 1 DRUM (12527-0254-9) | September 1, 2018 |
| 47049-044-00 | 47049-044 | Patheon France S.A.S. | 114285 TABLET, FILM COATED in 1 DRUM (47049-044-00) | April 1, 2026 |
| 47049-045-00 | 47049-045 | Patheon France S.A.S. | 114285 TABLET, FILM COATED in 1 DRUM (47049-045-00) | April 1, 2026 |
| 47049-046-00 | 47049-046 | Patheon France S.A.S. | 114285 TABLET, FILM COATED in 1 DRUM (47049-046-00) | April 1, 2026 |
| 47049-047-00 | 47049-047 | Patheon France S.A.S. | 114285 TABLET, FILM COATED in 1 DRUM (47049-047-00) | April 1, 2026 |
| 47049-048-00 | 47049-048 | Patheon France S.A.S. | 114285 TABLET, FILM COATED in 1 DRUM (47049-048-00) | April 1, 2026 |
| 70710-2156-8 | 70710-2156 | Zydus Pharmaceuticals USA Inc | 9 TABLET, FILM COATED in 1 BOTTLE (70710-2156-8) | September 18, 2026 |
| 70710-2156-9 | 70710-2156 | Zydus Pharmaceuticals USA Inc | 90 TABLET, FILM COATED in 1 BOTTLE (70710-2156-9) | September 18, 2026 |
| 70710-2157-8 | 70710-2157 | Zydus Pharmaceuticals USA Inc | 9 TABLET, FILM COATED in 1 BOTTLE (70710-2157-8) | September 18, 2026 |
| 70710-2157-9 | 70710-2157 | Zydus Pharmaceuticals USA Inc | 90 TABLET, FILM COATED in 1 BOTTLE (70710-2157-9) | September 18, 2026 |
| 70710-2158-8 | 70710-2158 | Zydus Pharmaceuticals USA Inc | 9 TABLET, FILM COATED in 1 BOTTLE (70710-2158-8) | September 18, 2026 |
| 70710-2158-9 | 70710-2158 | Zydus Pharmaceuticals USA Inc | 90 TABLET, FILM COATED in 1 BOTTLE (70710-2158-9) | September 18, 2026 |
| 70710-2159-8 | 70710-2159 | Zydus Pharmaceuticals USA Inc | 9 TABLET, FILM COATED in 1 BOTTLE (70710-2159-8) | September 18, 2026 |
| 70710-2159-9 | 70710-2159 | Zydus Pharmaceuticals USA Inc | 90 TABLET, FILM COATED in 1 BOTTLE (70710-2159-9) | September 18, 2026 |
| 70710-2160-8 | 70710-2160 | Zydus Pharmaceuticals USA Inc | 9 TABLET, FILM COATED in 1 BOTTLE (70710-2160-8) | September 18, 2026 |
| 70710-2160-9 | 70710-2160 | Zydus Pharmaceuticals USA Inc | 90 TABLET, FILM COATED in 1 BOTTLE (70710-2160-9) | September 18, 2026 |
| 12527-0250 | 12527-0250 | Bayer AG | — | September 1, 2018 |
| 12527-0251 | 12527-0251 | Bayer AG | — | September 1, 2018 |
| 12527-0252 | 12527-0252 | Bayer AG | — | September 1, 2018 |
| 12527-0253 | 12527-0253 | Bayer AG | — | September 1, 2018 |
| 12527-0254 | 12527-0254 | Bayer AG | — | September 1, 2018 |
| 47049-044 | 47049-044 | Patheon France S.A.S. | — | April 1, 2026 |
| 47049-045 | 47049-045 | Patheon France S.A.S. | — | April 1, 2026 |
| 47049-046 | 47049-046 | Patheon France S.A.S. | — | April 1, 2026 |
| 47049-047 | 47049-047 | Patheon France S.A.S. | — | April 1, 2026 |
| 47049-048 | 47049-048 | Patheon France S.A.S. | — | April 1, 2026 |
| 70710-2156 | 70710-2156 | Zydus Pharmaceuticals USA Inc | — | September 18, 2026 |
| 70710-2157 | 70710-2157 | Zydus Pharmaceuticals USA Inc | — | September 18, 2026 |
| 70710-2158 | 70710-2158 | Zydus Pharmaceuticals USA Inc | — | September 18, 2026 |
| 70710-2159 | 70710-2159 | Zydus Pharmaceuticals USA Inc | — | September 18, 2026 |
| 70710-2160 | 70710-2160 | Zydus Pharmaceuticals USA Inc | — | September 18, 2026 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.