BALVERSA

Product NDC: 59676-030
11-digit product format: 596760030
Labeler code: 59676
Product ID: 59676-030_41ec18e6-999d-f298-e063-6294a90aa2dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erdafitinib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Janssen Products LP
Application: NDA212018
Marketing category: NDA
Marketing start: 2019-04-12
Substance: ERDAFITINIB
Active strength: 3 mg/1
Pharmacologic classes: Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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	RLD / RS	Approval date
N212018-001	BALVERSA	ERDAFITINIB	3MG	TABLET / ORAL	RLD	2019-04-12
N212018-002	BALVERSA	ERDAFITINIB	4MG	TABLET / ORAL	RLD	2019-04-12
N212018-003	BALVERSA	ERDAFITINIB	5MG	TABLET / ORAL	RLD, RS	2019-04-12

Orange Book patents#

Current patent rows page 1 of 1 · 51 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212018-001	9464071	2031-04-28	U-3805		2019-05-03
N212018-001	8895601	2033-04-12		Drug substance, Drug product	2019-05-03
N212018-001	9902714	2035-03-26		Drug product	2019-05-03
N212018-001	12037644	2035-10-18	U-3972		2024-08-15
N212018-001	10898482	2036-02-09	U-2518	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3065	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3066	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3067	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3805	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3806	Drug product	2021-02-19
N212018-001	10898482	2036-02-09	U-3807	Drug product	2021-02-19
N212018-001	11684620	2036-02-09	U-3805		2023-07-26
N212018-001	11684620	2036-02-09	U-3806		2023-07-26
N212018-001	11684620	2036-02-09	U-3807		2023-07-26
N212018-001	10478494	2036-08-13	U-3902		2024-05-10
N212018-001	11077106	2038-02-02	U-3196		2021-08-27
N212018-001	11077106	2038-02-02	U-3808		2021-08-27
N212018-002	9464071	2031-04-28	U-3805		2019-05-03
N212018-002	8895601	2033-04-12		Drug substance, Drug product	2019-05-03
N212018-002	9902714	2035-03-26		Drug product	2019-05-03
N212018-002	12037644	2035-10-18	U-3972		2024-08-15
N212018-002	10898482	2036-02-09	U-2518	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3065	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3066	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3067	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3805	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3806	Drug product	2021-02-19
N212018-002	10898482	2036-02-09	U-3807	Drug product	2021-02-19
N212018-002	11684620	2036-02-09	U-3805		2023-07-26
N212018-002	11684620	2036-02-09	U-3806		2023-07-26
N212018-002	11684620	2036-02-09	U-3807		2023-07-26
N212018-002	10478494	2036-08-13	U-3902		2024-05-10
N212018-002	11077106	2038-02-02	U-3196		2021-08-27
N212018-002	11077106	2038-02-02	U-3808		2021-08-27
N212018-003	9464071	2031-04-28	U-3805		2019-05-03
N212018-003	8895601	2033-04-12		Drug substance, Drug product	2019-05-03
N212018-003	9902714	2035-03-26		Drug product	2019-05-03
N212018-003	12037644	2035-10-18	U-3972		2024-08-15
N212018-003	10898482	2036-02-09	U-2518	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3065	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3066	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3067	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3805	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3806	Drug product	2021-02-19
N212018-003	10898482	2036-02-09	U-3807	Drug product	2021-02-19
N212018-003	11684620	2036-02-09	U-3805		2023-07-26
N212018-003	11684620	2036-02-09	U-3806		2023-07-26
N212018-003	11684620	2036-02-09	U-3807		2023-07-26
N212018-003	10478494	2036-08-13	U-3902		2024-05-10
N212018-003	11077106	2038-02-02	U-3196		2021-08-27
N212018-003	11077106	2038-02-02	U-3808		2021-08-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212018-001	I-930	2027-01-19
N212018-002	I-930	2027-01-19
N212018-003	I-930	2027-01-19

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212018-002	BALVERSA	4MG	TABLET / ORAL	RLD	2019-04-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212018-003	BALVERSA	5MG	TABLET / ORAL	RLD, RS	2019-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212018-001	BALVERSA	3MG	TABLET / ORAL	RLD	2019-04-12	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 34 · 1,335 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212018-001	9464071	2031-04-28	U-3805		2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	8895601	2033-04-12		Drug substance, Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	9902714	2035-03-26		Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	12037644	2035-10-18	U-3972		2024-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3066	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3065	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3067	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-2518	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3805	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3807	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10898482	2036-02-09	U-3806	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	11684620	2036-02-09	U-3805		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	11684620	2036-02-09	U-3807		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	11684620	2036-02-09	U-3806		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	10478494	2036-08-13	U-3902		2024-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	11077106	2038-02-02	U-3196		2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-001	11077106	2038-02-02	U-3808		2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	9464071	2031-04-28	U-3805		2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	8895601	2033-04-12		Drug substance, Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	9902714	2035-03-26		Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	12037644	2035-10-18	U-3972		2024-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3067	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3066	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-2518	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3065	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3806	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3807	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10898482	2036-02-09	U-3805	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	11684620	2036-02-09	U-3805		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	11684620	2036-02-09	U-3807		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	11684620	2036-02-09	U-3806		2023-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	10478494	2036-08-13	U-3902		2024-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	11077106	2038-02-02	U-3196		2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	11077106	2038-02-02	U-3808		2021-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	9464071	2031-04-28	U-3805		2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	8895601	2033-04-12		Drug substance, Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	9902714	2035-03-26		Drug product	2019-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	12037644	2035-10-18	U-3972		2024-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	10898482	2036-02-09	U-3067	Drug product	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	10898482	2036-02-09	U-3066	Drug product	2021-02-19	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 153 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212018-001	I-930	2027-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-002	I-930	2027-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212018-003	I-930	2027-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-001	I-930	2027-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-002	I-930	2027-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212018-003	I-930	2027-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212018-001	I-930	2027-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212018-002	I-930	2027-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212018-003	I-930	2027-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-001	I-930	2027-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-002	I-930	2027-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212018-003	I-930	2027-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-001	I-930	2027-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-002	I-930	2027-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212018-003	I-930	2027-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-001	NCE	2024-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-001	I-930	2027-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-002	NCE	2024-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-002	I-930	2027-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-003	NCE	2024-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212018-003	I-930	2027-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-001	NCE	2024-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-001	I-930	2027-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-002	NCE	2024-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-002	I-930	2027-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-003	NCE	2024-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212018-003	I-930	2027-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-001	NCE	2024-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-001	I-930	2027-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-002	NCE	2024-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-002	I-930	2027-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-003	NCE	2024-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212018-003	I-930	2027-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-001	NCE	2024-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-001	I-930	2027-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-002	NCE	2024-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-002	I-930	2027-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-003	NCE	2024-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212018-003	I-930	2027-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212018-001	NCE	2024-04-12	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: BALVERSA
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ERDAFITINIB	3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
890E37NHMV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2123131	Internal RxNorm lookup
2123137	Internal RxNorm lookup
2123139	Internal RxNorm lookup
2123141	Internal RxNorm lookup
2123143	Internal RxNorm lookup
2123145	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
47af0703-f48e-48ba-b2b6-8560edffa830	Product name	1	20190710
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59676-030-56	BALVERSA	56 in 1 BOTTLE	TABLET, FILM COATED	56	14
59676-030-56	BALVERSA	1 in 1 CARTON	TABLET, FILM COATED	1	14
59676-030-84	BALVERSA	1 in 1 CARTON	TABLET, FILM COATED	1	14
59676-030-84	BALVERSA	84 in 1 BOTTLE	TABLET, FILM COATED	84	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59676-030-56	EA - Each	59676-030	c24ca732-dc24-4812-9f0a-dbf06e331df6	1	2019-05-02
59676-030-84	EA - Each	59676-030	747dc67b-e106-4f9c-ad09-254284a17b43	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59676-030	BALVERSA (ERDAFITINIB) TABLET, FILM COATED [JANSSEN PRODUCTS LP]	13	Current NDC, Legacy NDC, 4 package rows	20241114_2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee.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
BALVERSA	ERDAFITINIB	Janssen Products LP	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212018 application number: NDA212018 ndc (product): 59676-030

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
890E37NHMV	ERDAFITINIB	1346242-81-6	ERDAFITINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2123137	Balversa 3 MG Oral Tablet	PSN	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123141	Balversa 4 MG Oral Tablet	PSN	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123145	Balversa 5 MG Oral Tablet	PSN	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123131	erdafitinib 3 MG Oral Tablet	PSN	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123139	erdafitinib 4 MG Oral Tablet	PSN	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123143	erdafitinib 5 MG Oral Tablet	PSN	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123137	erdafitinib 3 MG Oral Tablet [Balversa]	SBD	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123141	erdafitinib 4 MG Oral Tablet [Balversa]	SBD	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123145	erdafitinib 5 MG Oral Tablet [Balversa]	SBD	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123131	erdafitinib 3 MG Oral Tablet	SCD	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123139	erdafitinib 4 MG Oral Tablet	SCD	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123143	erdafitinib 5 MG Oral Tablet	SCD	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123137	Balversa 3 MG Oral Tablet	SY	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123141	Balversa 4 MG Oral Tablet	SY	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14
2123145	Balversa 5 MG Oral Tablet	SY	2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59676-030-56	59676003056	1 BOTTLE in 1 CARTON (59676-030-56) / 56 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-04-12	0000-00-00	No	No	Current
59676-030-84	59676003084	1 BOTTLE in 1 CARTON (59676-030-84) / 84 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-04-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BALVERSA	Janssen Products LP \| Cilag AG \| Johnson & Johnson Private Limited \| Janssen Cilag SpA	2025-10-24	HUMAN PRESCRIPTION DRUG LABEL	14