VANRAFIA

Product NDC
0078-1420
11-digit product format
000781420
Labeler code
0078
Product ID
0078-1420_48384e66-f6ff-4b6e-81e2-0a7ac05e8627
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atrasentan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA219208
Marketing category
NDA
Marketing start
2025-04-02
Substance
ATRASENTAN HYDROCHLORIDE
Active strength
.75 mg/1
Pharmacologic classes
Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219208-001VANRAFIAATRASENTAN HYDROCHLORIDEEQ 0.75MG BASETABLET / ORALRLD, RS2025-04-02

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219208-00186238192028-08-22U-39802025-04-29
N219208-001118742832032-02-18U-39802025-04-29
N219208-001100163932034-07-07Drug product2025-04-29
N219208-00193644582034-07-07U-3980Drug product2025-04-29
N219208-001114911372040-12-16U-39802025-04-29
N219208-001119985262040-12-16U-39802025-04-29
N219208-001121215092040-12-16U-39802025-04-29
N219208-001123701742040-12-16U-39802025-08-21
N219208-001125213692041-03-02U-39802026-02-06
N219208-001125826312043-03-25U-39802026-04-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219208-001NCE2030-04-02

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N219208-001VANRAFIAEQ 0.75MG BASETABLET / ORALRLD, RS2025-04-0284e616aacf4f…
2026-08-18 06:07:402026-07N219208-001VANRAFIAEQ 0.75MG BASETABLET / ORALRLD, RS2025-04-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219208-001VANRAFIAEQ 0.75MG BASETABLET / ORALRLD, RS2025-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219208-001VANRAFIAEQ 0.75MG BASETABLET / ORALRLD, RS2025-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N219208-001VANRAFIAEQ 0.75MG BASETABLET / ORALRLD, RS2025-04-026a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219208-001VANRAFIAEQ 0.75MG BASETABLET / ORALRLD, RS2025-04-02a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219208-00186238192028-08-22U-39802025-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N219208-001118742832032-02-18U-39802025-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N219208-001100163932034-07-07Drug product2025-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N219208-00193644582034-07-07U-3980Drug product2025-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N219208-001114911372040-12-16U-39802025-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N219208-001119985262040-12-16U-39802025-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N219208-001121215092040-12-16U-39802025-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N219208-001123701742040-12-16U-39802025-08-2184e616aacf4f…
2026-09-14 22:38:342026-08N219208-001125213692041-03-02U-39802026-02-0684e616aacf4f…
2026-09-14 22:38:342026-08N219208-001125826312043-03-25U-39802026-04-0784e616aacf4f…
2026-08-18 06:07:402026-07N219208-00186238192028-08-22U-39802025-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219208-001118742832032-02-18U-39802025-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219208-001100163932034-07-07Drug product2025-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219208-00193644582034-07-07U-3980Drug product2025-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219208-001114911372040-12-16U-39802025-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219208-001119985262040-12-16U-39802025-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219208-001121215092040-12-16U-39802025-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N219208-001123701742040-12-16U-39802025-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07N219208-001125213692041-03-02U-39802026-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07N219208-001125826312043-03-25U-39802026-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219208-00186238192028-08-22U-39802025-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219208-001118742832032-02-18U-39802025-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219208-001100163932034-07-07Drug product2025-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219208-00193644582034-07-07U-3980Drug product2025-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219208-001114911372040-12-16U-39802025-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219208-001119985262040-12-16U-39802025-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219208-001121215092040-12-16U-39802025-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219208-001123701742040-12-16U-39802025-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219208-001125213692041-02-23U-39802026-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219208-00186238192028-08-22U-39802025-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219208-001118742832032-02-18U-39802025-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219208-001100163932034-07-07Drug product2025-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219208-00193644582034-07-07U-3980Drug product2025-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219208-001114911372040-12-16U-39802025-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219208-001119985262040-12-16U-39802025-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219208-001121215092040-12-16U-39802025-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219208-001123701742040-12-16U-39802025-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N219208-00186238192028-08-22U-39802025-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219208-001118742832032-02-18U-39802025-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219208-001100163932034-07-07Drug product2025-04-296a471c1ec25d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N219208-001NCE2030-04-0284e616aacf4f…
2026-08-18 06:07:402026-07N219208-001NCE2030-04-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219208-001NCE2030-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219208-001NCE2030-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N219208-001NCE2030-04-026a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219208-001NCE2030-04-02a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
VANRAFIA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATRASENTAN HYDROCHLORIDE.75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E4G31X93ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2710454Internal RxNorm lookup
2710460Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a7e7f85-bfd0-44a0-beda-3bcfa8215c64Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6cdd289-bd1a-41c9-ae60-baec4413ad90Product name120260112
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-1420-15VANRAFIA30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1420-15EA - Each0078-142080ef8d3d-2077-483a-87e8-0c05f2eb00a412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-1420VANRAFIA (ATRASENTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]1Current NDC, 1 package rows20250406_9a7e7f85-bfd0-44a0-beda-3bcfa8215c64.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VANRAFIAATRASENTANNovartis Pharmaceuticals Corporation9a7e7f85-bfd0-44a0-beda-3bcfa8215c642026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 219208
application number: NDA219208
ndc (product): 0078-1420

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2710454atrasentan 0.75 MG Oral TabletPSN9a7e7f85-bfd0-44a0-beda-3bcfa8215c642
2710460VANRAFIA 0.75 MG Oral TabletPSN9a7e7f85-bfd0-44a0-beda-3bcfa8215c642
2710460atrasentan 0.75 MG Oral Tablet [Vanrafia]SBD9a7e7f85-bfd0-44a0-beda-3bcfa8215c642
2710454atrasentan 0.75 MG Oral TabletSCD9a7e7f85-bfd0-44a0-beda-3bcfa8215c642
2710454atrasentan 0.75 MG (equivalent to atrasentan hydrochloride 0.803 MG) Oral TabletSY9a7e7f85-bfd0-44a0-beda-3bcfa8215c642
2710460Vanrafia 0.75 MG (equivalent to atrasentan hydrochloride 0.803 MG) Oral TabletSY9a7e7f85-bfd0-44a0-beda-3bcfa8215c642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0078-1420-150007814201530 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15) 2025-04-02NoNoCurrent