Home NDC 0078-0713 Jadenu
Product NDC 0078-0713
11-digit product format 000780713
Labeler code 0078
Product ID 0078-0713_028e6158-3b78-41dd-99a8-6acb582f7245
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name deferasirox
Dosage form GRANULE
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA207968
Marketing category NDA
Marketing start 2017-05-18
Substance DEFERASIROX
Active strength 180 mg/1
Pharmacologic classes Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Iron Chelating Activity [MoA], Iron Chelator [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207968-001 JADENU SPRINKLE DEFERASIROX 90MG GRANULE / ORAL AB RLD 2017-05-18 N207968-002 JADENU SPRINKLE DEFERASIROX 180MG GRANULE / ORAL AB RLD 2017-05-18 N207968-003 JADENU SPRINKLE DEFERASIROX 360MG GRANULE / ORAL AB RLD, RS 2017-05-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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.
Product history page 1 of 4 · 123 observed 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 2026-02-19 14:30 UTC 2026-02 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207968-002 JADENU SPRINKLE 180MG GRANULE / ORAL AB RLD 2017-05-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207968-003 JADENU SPRINKLE 360MG GRANULE / ORAL AB RLD, RS 2017-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207968-001 JADENU SPRINKLE 90MG GRANULE / ORAL AB RLD 2017-05-18 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N207968-001 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207968-002 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207968-003 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N207968-001 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N207968-002 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N207968-003 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207968-001 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N207968-002 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N207968-003 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207968-001 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N207968-002 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N207968-003 6465504 2019-04-05 Drug substance, Drug product 2017-06-06 ea99ee380514…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 138 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Jadenu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFERASIROX 180 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V8G4MOF2V9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1607784 Internal RxNorm lookup 1607790 Internal RxNorm lookup 1607792 Internal RxNorm lookup 1607794 Internal RxNorm lookup 1607796 Internal RxNorm lookup 1607798 Internal RxNorm lookup 1923822 Internal RxNorm lookup 1923825 Internal RxNorm lookup 1923826 Internal RxNorm lookup 1923827 Internal RxNorm lookup 1923828 Internal RxNorm lookup 1923829 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 0078-0713-15 Jadenu 30 in 1 CARTON GRANULE 30 26 0078-0713-19 Jadenu 1 in 1 PACKET GRANULE 1 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEFERASIROX ACTIVE INGREDIENT V8G4MOF2V9 JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 4 DEFERASIROX ACTIVE MOIETY V8G4MOF2V9 JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 4 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 4 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0713 JADENU (DEFERASIROX) TABLET, FILM COATED JADENU (DEFERASIROX) GRANULE [NOVARTIS PHARMACEUTICALS CORPORATION] 23 Current NDC, Legacy NDC, 2 package rows 20250503_fee89140-fff1-4443-9f42-24ac004fcda1.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 Jadenu DEFERASIROX Novartis Pharmaceuticals Corporation fee89140-fff1-4443-9f42-24ac004fcda1 2025-12-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 207968 application number: NDA207968 ndc (product): 0078-0713
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0713-15 00078071315 30 PACKET in 1 CARTON (0078-0713-15) / 1 GRANULE in 1 PACKET (0078-0713-19) 30 packet 2017-05-18 0000-00-00 No No Current 0078-0713-19 00078071319 1 in 1 PACKET Historical