Home NDC 0078-1420 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219208-001 VANRAFIA ATRASENTAN HYDROCHLORIDE EQ 0.75MG BASE TABLET / ORAL RLD, RS 2025-04-02
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219208-001 8623819 2028-08-22 U-3980 2025-04-29 N219208-001 11874283 2032-02-18 U-3980 2025-04-29 N219208-001 10016393 2034-07-07 Drug product 2025-04-29 N219208-001 9364458 2034-07-07 U-3980 Drug product 2025-04-29 N219208-001 11491137 2040-12-16 U-3980 2025-04-29 N219208-001 11998526 2040-12-16 U-3980 2025-04-29 N219208-001 12121509 2040-12-16 U-3980 2025-04-29 N219208-001 12370174 2040-12-16 U-3980 2025-08-21 N219208-001 12521369 2041-03-02 U-3980 2026-02-06 N219208-001 12582631 2043-03-25 U-3980 2026-04-07
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219208-001 NCE 2030-04-02
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N219208-001 VANRAFIA EQ 0.75MG BASE TABLET / ORAL RLD, RS 2025-04-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219208-001 VANRAFIA EQ 0.75MG BASE TABLET / ORAL RLD, RS 2025-04-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219208-001 VANRAFIA EQ 0.75MG BASE TABLET / ORAL RLD, RS 2025-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219208-001 VANRAFIA EQ 0.75MG BASE TABLET / ORAL RLD, RS 2025-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219208-001 VANRAFIA EQ 0.75MG BASE TABLET / ORAL RLD, RS 2025-04-02 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219208-001 VANRAFIA EQ 0.75MG BASE TABLET / ORAL RLD, RS 2025-04-02 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 54 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N219208-001 8623819 2028-08-22 U-3980 2025-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219208-001 11874283 2032-02-18 U-3980 2025-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219208-001 10016393 2034-07-07 Drug product 2025-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219208-001 9364458 2034-07-07 U-3980 Drug product 2025-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219208-001 11491137 2040-12-16 U-3980 2025-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219208-001 11998526 2040-12-16 U-3980 2025-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219208-001 12121509 2040-12-16 U-3980 2025-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219208-001 12370174 2040-12-16 U-3980 2025-08-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219208-001 12521369 2041-03-02 U-3980 2026-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219208-001 12582631 2043-03-25 U-3980 2026-04-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219208-001 8623819 2028-08-22 U-3980 2025-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219208-001 11874283 2032-02-18 U-3980 2025-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219208-001 10016393 2034-07-07 Drug product 2025-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219208-001 9364458 2034-07-07 U-3980 Drug product 2025-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219208-001 11491137 2040-12-16 U-3980 2025-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219208-001 11998526 2040-12-16 U-3980 2025-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219208-001 12121509 2040-12-16 U-3980 2025-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219208-001 12370174 2040-12-16 U-3980 2025-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219208-001 12521369 2041-03-02 U-3980 2026-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219208-001 12582631 2043-03-25 U-3980 2026-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219208-001 8623819 2028-08-22 U-3980 2025-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219208-001 11874283 2032-02-18 U-3980 2025-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219208-001 10016393 2034-07-07 Drug product 2025-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219208-001 9364458 2034-07-07 U-3980 Drug product 2025-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219208-001 11491137 2040-12-16 U-3980 2025-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219208-001 11998526 2040-12-16 U-3980 2025-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219208-001 12121509 2040-12-16 U-3980 2025-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219208-001 12370174 2040-12-16 U-3980 2025-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219208-001 12521369 2041-02-23 U-3980 2026-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219208-001 8623819 2028-08-22 U-3980 2025-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219208-001 11874283 2032-02-18 U-3980 2025-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219208-001 10016393 2034-07-07 Drug product 2025-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219208-001 9364458 2034-07-07 U-3980 Drug product 2025-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219208-001 11491137 2040-12-16 U-3980 2025-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219208-001 11998526 2040-12-16 U-3980 2025-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219208-001 12121509 2040-12-16 U-3980 2025-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219208-001 12370174 2040-12-16 U-3980 2025-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219208-001 8623819 2028-08-22 U-3980 2025-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219208-001 11874283 2032-02-18 U-3980 2025-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219208-001 10016393 2034-07-07 Drug product 2025-04-29 6a471c1ec25d…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 N219208-001 NCE 2030-04-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219208-001 NCE 2030-04-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219208-001 NCE 2030-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219208-001 NCE 2030-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219208-001 NCE 2030-04-02 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219208-001 NCE 2030-04-02 a50c72e98297…
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 Ingredient Strength ATRASENTAN HYDROCHLORIDE .75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination E4G31X93ZA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2710454 Internal RxNorm lookup 2710460 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-1420-15 VANRAFIA 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-1420 VANRAFIA (ATRASENTAN) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 1 Current NDC, 1 package rows 20250406_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VANRAFIA ATRASENTAN Novartis Pharmaceuticals Corporation 9a7e7f85-bfd0-44a0-beda-3bcfa8215c64 2026-06-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 219208 application number: NDA219208 ndc (product): 0078-1420
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0078-1420-15 00078142015 30 TABLET, FILM COATED in 1 BOTTLE (0078-1420-15) 2025-04-02 No No Current