U.S. drug safety preview
Warfarin
This preview shows whether PillRight has enough official U.S. source coverage to build a public medication safety page. It is not a dosage guide, treatment recommendation, or substitute for a clinician or pharmacist.
Last reviewed: June 12, 2026
Readiness snapshot
- Concept identity
- Ready
RxNorm 11289 (IN)
- Official label
- Ready
A non-fixture DailyMed SPL label is attached.
- Approval context
- Ready
A non-fixture Drugs@FDA or Orange Book approval-context source is attached.
- Publication
- Ready
All source references are promoted
Public page modules not yet published
These sections remain preview-only until the official U.S. release gate and index switch are approved.
Official label summary
ReadyCopy schema passedSource, copy, and final review passed.
Interaction and duplicate ingredient checks
ReadyCopy schema passedSource, copy, and final review passed.
Pregnancy and breastfeeding source notes
ReadyCopy schema passedSource, copy, and final review passed.
Side effects and warning sections
ReadyCopy schema passedSource, copy, and final review passed.
Next release actions
Actionable review steps for this drug before the U.S. page can move toward public release.
Source coverage matrix
Required official source slots and whether each one is publication-grade, fixture-only, or still missing.
RxNorm identity
PassedPrimary RxCUI 11289 matches the RxNorm source reference.
1 attached reference
- RxNorm: RxCUI 11289 (IN)
DailyMed SPL label
PassedA non-fixture DailyMed SPL label is attached.
2 attached references
- DailyMed: DailyMed set ID fixture-warfarin-label-search (search_seed)
- DailyMed: DailyMed set ID 558b7a0d-5490-4c1b-802e-3ab3f1efe760 (spl_label)
FDA approval context
PassedA non-fixture Drugs@FDA or Orange Book approval-context source is attached.
1 attached reference
- Orange Book: Application ANDA040416 / TE AB
Internal review workspace
Source mapping, candidate decisions, and publication blockers remain visible here while this route is excluded from indexing.
Concept identity
- Display name
- Warfarin
- Slug
- warfarin
- Primary RxCUI
- 11289
- RxNorm term type
- IN
- Concept kind
- Ingredient
- Review status
- Reviewed
- Publishable
- Yes
- Aliases
- None
Review checklist
These checks decide whether a U.S. fixture can move toward a source-mapped or reviewed state.
RxNorm concept verified
PassedPrimary RxCUI 11289 matches the RxNorm source reference.
DailyMed label candidate attached
PassedA non-fixture DailyMed SPL label is attached.
FDA approval context reviewed
PassedA non-fixture Drugs@FDA or Orange Book approval-context source is attached.
NDC listing boundary checked
PassedNo NDC listing is treated as FDA approval evidence.
Manual publication review completed
PassedThe concept has passed the final U.S. publication review state.
Public index surfaces excluded
PassedThe U.S. preview route remains noindex and is excluded from sitemap and llms.txt tests.
No medical advice copy
PassedThe fixture review page shows identity and source references only, not dosage, indication, or treatment guidance.
Dry-run preview
Local sample output for the current RxNorm and DailyMed mapping flow. This preview does not update fixtures or publish U.S. pages.
RxNorm lookup
- Query
- warfarin
- Primary match
- Yes
- Candidates
- 11289
DailyMed SPL candidates
2 search-only candidates normalized from the local sample.
558b7a0d-5490-4c1b-802e-3ab3f1efe760 · search_seed
Score 85 · Likely matchWARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS LLC]
Jun 03, 2026
Reasons
- Title contains exact ingredient term: Warfarin.
- DailyMed setId is present.
- Published date is present.
- Title appears to describe a single-ingredient candidate.
Review warnings
- Search result is not a reviewed SPL label selection.
- Approval context still requires Drugs@FDA or Orange Book review.
52bacf1e-9ba8-7eca-e063-6394a90ab60b · search_seed
Score 85 · Likely matchWARFARIN SODIUM (WARFARIN) TABLET [COUPLER LLC]
May 28, 2026
Reasons
- Title contains exact ingredient term: Warfarin.
- DailyMed setId is present.
- Published date is present.
- Title appears to describe a single-ingredient candidate.
Review warnings
- Search result is not a reviewed SPL label selection.
- Approval context still requires Drugs@FDA or Orange Book review.
Approval context candidates
2 review-only candidates normalized from FDA application data.
Drugs@FDA · ANDA040416 / 001
JANTOVEN · WARFARIN SODIUM
- Status
- Prescription
- Form
- TABLET
- Route
- ORAL
- TE code
- AB
Reasons
- Active ingredient contains exact concept term: Warfarin.
- Application number is present: ANDA040416.
- Product number is present: 001.
- Marketing status is present: Prescription.
- Dosage form and route are present: TABLET / ORAL.
- Orange Book TE code is present: AB.
Review warnings
- Review-only approval candidate; not promoted to source references.
- Manual Drugs@FDA or Orange Book verification is required before publication.
Orange Book · ANDA040416 / 001
JANTOVEN · WARFARIN SODIUM
- Status
- Prescription
- Form
- TABLET
- Route
- ORAL
- TE code
- AB
Reasons
- Active ingredient contains exact concept term: Warfarin.
- Application number is present: ANDA040416.
- Product number is present: 001.
- Marketing status is present: Prescription.
- Dosage form and route are present: TABLET / ORAL.
- Orange Book TE code is present: AB.
Review warnings
- Review-only approval candidate; not promoted to source references.
- Manual Drugs@FDA or Orange Book verification is required before publication.
Review decisions
Manual candidate decisions are recorded separately from source references. Approved decisions still require explicit source promotion before publication.
- Current status
- Reviewed
- Eligible next status
- Blocked
- Promotion required
- No
DailyMed SPL
558b7a0d-5490-4c1b-802e-3ab3f1efe760 - WARFARIN SODIUM (WARFARIN) TABLET [AMNEAL PHARMACEUTICALS LLC]
Approve as a single-ingredient warfarin sodium DailyMed SPL candidate for source mapping review.
2026-06-12 · internal-review
DailyMed SPL
52bacf1e-9ba8-7eca-e063-6394a90ab60b - WARFARIN SODIUM (WARFARIN) TABLET [COUPLER LLC]
Reject as a non-selected DailyMed candidate because the Amneal SPL record is the reviewed Warfarin label anchor for this pass.
2026-06-12 · internal-review
Approval context
drugs_fda ANDA040416/001 - JANTOVEN
Reject for this pass because the matching Orange Book record is the selected approval-context anchor for Warfarin.
2026-06-12 · internal-review
Approval context
orange_book ANDA040416/001 - JANTOVEN
Approve as an Orange Book review candidate with product-level warfarin sodium and TE AB context.
2026-06-12 · internal-review
Publication blockers
- Missing non-fixture DailyMed SPL label reference.
- Missing Drugs@FDA or Orange Book approval-context reference.
Keep this result as noindex review data until the blockers are resolved.
Official source references
RxNorm
U.S. National Library of Medicine
- Reference
- RxCUI 11289 (IN)
- Reviewed
- 2026-06-11
- Fixture only
- No
DailyMed
U.S. National Library of Medicine
- Reference
- DailyMed set ID fixture-warfarin-label-search (search_seed)
- Reviewed
- 2026-06-11
- Fixture only
- Yes
DailyMed
U.S. National Library of Medicine
- Reference
- DailyMed set ID 558b7a0d-5490-4c1b-802e-3ab3f1efe760 (spl_label)
- Reviewed
- 2026-06-12
- Fixture only
- No
Orange Book
U.S. Food and Drug Administration
- Reference
- Application ANDA040416 / TE AB
- Reviewed
- 2026-06-12
- Fixture only
- No
openFDA drug labeling
U.S. Food and Drug Administration
- Reference
- openfda.generic_name:warfarin
- Reviewed
- 2026-06-11
- Fixture only
- Yes
Medical disclaimer
This internal U.S. review page does not explain indications, dosage, interactions, side effects, or personal medication decisions. Review the official label and ask a licensed clinician or pharmacist before making medication decisions.
Read the U.S. medical disclaimer