Afinitor

Product NDC: 0078-0627
11-digit product format: 000780627
Labeler code: 0078
Product ID: 0078-0627_79d3253f-e1e3-428f-8dd4-4f2fe76faa15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: everolimus
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA203985
Marketing category: NDA
Marketing start: 2012-08-29
Substance: EVEROLIMUS
Active strength: 3 mg/1
Pharmacologic classes: Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [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 42.

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
N203985-001	AFINITOR DISPERZ	EVEROLIMUS	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29
N203985-002	AFINITOR DISPERZ	EVEROLIMUS	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29
N203985-003	AFINITOR DISPERZ	EVEROLIMUS	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N203985-001	AB
N203985-002	AB
N203985-003	AB

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 · 126 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
2026-08-18 06:07:40	2026-07	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-002	AFINITOR DISPERZ	3MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-003	AFINITOR DISPERZ	5MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2012-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-001	AFINITOR DISPERZ	2MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2012-08-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N203985-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203985-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203985-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203985-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203985-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203985-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203985-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203985-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-001	AB	1	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 348 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	8778962	2022-02-18	U-1541		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	8778962	2022-02-18	U-2280		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	8778962*PED	2022-08-18		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	8617598	2022-09-27		Drug product	2014-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	8617598*PED	2023-03-27		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-002	8778962	2022-02-18	U-1541		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-002	8778962	2022-02-18	U-2280		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-002	8778962*PED	2022-08-18		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-002	8617598	2022-09-27		Drug product	2014-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-002	8617598*PED	2023-03-27		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-003	8778962	2022-02-18	U-1541		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-003	8778962	2022-02-18	U-2280		2014-07-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-003	8778962*PED	2022-08-18		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-003	8617598	2022-09-27		Drug product	2014-03-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-003	8617598*PED	2023-03-27		Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203985-001	8778962	2022-02-18	U-1541		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-001	8778962	2022-02-18	U-2280		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-001	8778962*PED	2022-08-18		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-001	8617598	2022-09-27		Drug product	2014-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-001	8617598*PED	2023-03-27		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-002	8778962	2022-02-18	U-1541		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-002	8778962	2022-02-18	U-2280		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-002	8778962*PED	2022-08-18		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-002	8617598	2022-09-27		Drug product	2014-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-002	8617598*PED	2023-03-27		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-003	8778962	2022-02-18	U-1541		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-003	8778962	2022-02-18	U-2280		2014-07-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-003	8778962*PED	2022-08-18		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-003	8617598	2022-09-27		Drug product	2014-03-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203985-003	8617598*PED	2023-03-27		Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203985-001	8778962	2022-02-18	U-1541		2014-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-001	8778962	2022-02-18	U-2280		2014-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-001	8778962*PED	2022-08-18		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-001	8617598	2022-09-27		Drug product	2014-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-001	8617598*PED	2023-03-27		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-002	8778962	2022-02-18	U-1541		2014-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-002	8778962	2022-02-18	U-2280		2014-07-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-002	8778962*PED	2022-08-18		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-002	8617598	2022-09-27		Drug product	2014-03-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203985-002	8617598*PED	2023-03-27		Pediatric extension		`4b0b4de00fa7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-001	ODE-169	2025-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-002	ODE-169	2025-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203985-003	ODE-169	2025-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203985-001	ODE-169	2025-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-002	ODE-169	2025-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203985-003	ODE-169	2025-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-001	ODE-169	2025-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-002	ODE-169	2025-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203985-003	ODE-169	2025-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-001	ODE-169	2025-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-002	ODE-169	2025-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203985-003	ODE-169	2025-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-001	ODE-169	2025-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-002	ODE-169	2025-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203985-003	ODE-169	2025-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-001	ODE-169	2025-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-002	ODE-169	2025-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203985-003	ODE-169	2025-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-001	ODE-169	2025-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-002	ODE-169	2025-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203985-003	ODE-169	2025-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-001	ODE-169	2025-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-002	ODE-169	2025-04-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203985-003	ODE-169	2025-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203985-001	ODE-169	2025-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-002	ODE-169	2025-04-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203985-003	ODE-169	2025-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-001	ODE-169	2025-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-002	ODE-169	2025-04-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203985-003	ODE-169	2025-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-001	ODE-169	2025-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-002	ODE-169	2025-04-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203985-003	ODE-169	2025-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-001	ODE-169	2025-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-002	ODE-169	2025-04-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203985-003	ODE-169	2025-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203985-001	ODE-169	2025-04-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203985-002	ODE-169	2025-04-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203985-003	ODE-169	2025-04-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203985-001	ODE-169	2025-04-10	`5c6f7cd8ea54…`

Additional Listing Data#

Finished product: Yes
Brand name base: Afinitor
Brand name suffix: Disperz
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EVEROLIMUS	3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9HW64Q8G6G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
845507	Internal RxNorm lookup
845512	Internal RxNorm lookup
845515	Internal RxNorm lookup
845518	Internal RxNorm lookup
998189	Internal RxNorm lookup
998191	Internal RxNorm lookup
1119400	Internal RxNorm lookup
1119402	Internal RxNorm lookup
1308428	Internal RxNorm lookup
1308430	Internal RxNorm lookup
1308432	Internal RxNorm lookup
1310138	Internal RxNorm lookup
1310144	Internal RxNorm lookup
1310147	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
2150f73a-179b-4afc-b8ce-67c85cc72f04	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
807eb842-6749-6eff-f9ce-2751c69fde93	Product name	4	20260122
151279ee-9f3c-b884-3327-05b3fa99d863	Product name	6	20251027
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-08-01	These highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009
2023-08-01	These highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009
2023-07-28	These highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009
2023-07-28	These highlights do not include all the information needed to use AFINITOR/AFINITOR DISPERZ safely and effectively. See full prescribing information for AFINITOR/AFINITOR DISPERZ. AFINITOR ® (everolimus) tablets, for oral use AFINITOR DISPERZ ® (everolimus tablets for oral suspension) Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0078-0627-51	AfinitorDisperz	28 in 1 CARTON	TABLET, FOR SUSPENSION	28		66
0078-0627-61	AfinitorDisperz	1 in 1 BLISTER PACK	TABLET, FOR SUSPENSION	1		66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0627-51	EA - Each	0078-0627	df10573d-fa0f-43b6-983c-dadf78bbb8d7	1	2013-05-02
0078-0627-61	EA - Each	0078-0627	e0a0a43f-380b-4f49-8896-b7630673f962	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EVEROLIMUS	ACTIVE INGREDIENT	9HW64Q8G6G	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	34
EVEROLIMUS	ACTIVE MOIETY	9HW64Q8G6G	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	34
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	34
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	34
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	34
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	34
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	34
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	34
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	34
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	34
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0627	AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	64	Current NDC, Legacy NDC, 2 package rows	20250515_2150f73a-179b-4afc-b8ce-67c85cc72f04.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
Afinitor	EVEROLIMUS	Novartis Pharmaceuticals Corporation	2150f73a-179b-4afc-b8ce-67c85cc72f04	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203985 application number: NDA203985 ndc (product): 0078-0627

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9HW64Q8G6G	EVEROLIMUS	159351-69-6	EVEROLIMUS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
845512	AFINITOR 10 MG Oral Tablet	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
998191	AFINITOR 2.5 MG Oral Tablet	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
845518	AFINITOR 5 MG Oral Tablet	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1119402	AFINITOR 7.5 MG Oral Tablet	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1310138	AFINITOR DISPERZ 2 MG Tablet for Oral Suspension	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1310144	AFINITOR DISPERZ 3 MG Tablet for Oral Suspension	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1310147	AFINITOR DISPERZ 5 MG Tablet for Oral Suspension	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
845507	everolimus 10 MG Oral Tablet	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1308428	everolimus 2 MG Tablet for Oral Suspension	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
998189	everolimus 2.5 MG Oral Tablet	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1308430	everolimus 3 MG Tablet for Oral Suspension	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
845515	everolimus 5 MG Oral Tablet	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1308432	everolimus 5 MG Tablet for Oral Suspension	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1119400	everolimus 7.5 MG Oral Tablet	PSN	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
845512	everolimus 10 MG Oral Tablet [Afinitor]	SBD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1310138	everolimus 2 MG Tablet for Oral Suspension [Afinitor]	SBD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
998191	everolimus 2.5 MG Oral Tablet [Afinitor]	SBD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1310144	everolimus 3 MG Tablet for Oral Suspension [Afinitor]	SBD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
845518	everolimus 5 MG Oral Tablet [Afinitor]	SBD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1310147	everolimus 5 MG Tablet for Oral Suspension [Afinitor]	SBD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1119402	everolimus 7.5 MG Oral Tablet [Afinitor]	SBD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
845507	everolimus 10 MG Oral Tablet	SCD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1308428	everolimus 2 MG Tablet for Oral Suspension	SCD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
998189	everolimus 2.5 MG Oral Tablet	SCD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1308430	everolimus 3 MG Tablet for Oral Suspension	SCD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
845515	everolimus 5 MG Oral Tablet	SCD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1308432	everolimus 5 MG Tablet for Oral Suspension	SCD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1119400	everolimus 7.5 MG Oral Tablet	SCD	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
845512	Afinitor 10 MG Oral Tablet	SY	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
998191	Afinitor 2.5 MG Oral Tablet	SY	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
845518	Afinitor 5 MG Oral Tablet	SY	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1119402	Afinitor 7.5 MG Oral Tablet	SY	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1310138	Afinitor Disperz 2 MG Tablet for Oral Suspension	SY	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1310144	Afinitor Disperz 3 MG Tablet for Oral Suspension	SY	2150f73a-179b-4afc-b8ce-67c85cc72f04	66
1310147	Afinitor Disperz 5 MG Tablet for Oral Suspension	SY	2150f73a-179b-4afc-b8ce-67c85cc72f04	66

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0627-51	00078062751	28 BLISTER PACK in 1 CARTON (0078-0627-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0627-61)	28 blister pack	2012-08-29	0000-00-00	No	No	Current
0078-0627-61	00078062761	1 in 1 BLISTER PACK						Historical