Afinitor

Product NDC: 0078-0566
11-digit product format: 000780566
Labeler code: 0078
Product ID: 0078-0566_b808a4e0-23a8-40c8-834d-b31cd642febe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: everolimus
Dosage form: TABLET
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA022334
Marketing category: NDA
Marketing start: 2009-03-31
Substance: EVEROLIMUS
Active strength: 5 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 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022334-001	AFINITOR	EVEROLIMUS	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30
N022334-002	AFINITOR	EVEROLIMUS	10MG	TABLET / ORAL	AB	RLD	2009-03-30
N022334-003	AFINITOR	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09
N022334-004	AFINITOR	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022334-001	AB
N022334-002	AB
N022334-003	AB
N022334-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022334-001	8410131	2025-11-01	U-1368		2013-04-02
N022334-001	8410131*PED	2026-05-01		Pediatric extension
N022334-001	9006224	2028-07-01	U-1681		2015-04-20
N022334-002	8410131	2025-11-01	U-1368		2013-04-02
N022334-002	8410131*PED	2026-05-01		Pediatric extension
N022334-002	9006224	2028-07-01	U-1681		2015-04-20
N022334-003	8410131	2025-11-01	U-1368		2013-04-02
N022334-003	8410131*PED	2026-05-01		Pediatric extension
N022334-003	9006224	2028-07-01	U-1681		2015-04-20
N022334-004	8410131	2025-11-01	U-1368		2013-04-02
N022334-004	8410131*PED	2026-05-01		Pediatric extension
N022334-004	9006224	2028-07-01	U-1681		2015-04-20

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 5 · 176 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
2026-10-15 13:18:30	2026-09	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-001	AFINITOR	5MG	TABLET / ORAL	AB	RLD, RS	2009-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-002	AFINITOR	10MG	TABLET / ORAL	AB	RLD	2009-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-003	AFINITOR	2.5MG	TABLET / ORAL	AB	RLD	2010-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-004	AFINITOR	7.5MG	TABLET / ORAL	AB	RLD	2012-03-30	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N022334-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022334-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022334-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022334-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022334-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022334-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022334-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022334-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022334-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022334-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022334-004	AB	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 912 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022334-001	8410131	2025-11-01	U-1368		2013-04-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-001	8410131*PED	2026-05-01		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-001	9006224	2028-07-01	U-1681		2015-04-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-002	8410131	2025-11-01	U-1368		2013-04-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-002	8410131*PED	2026-05-01		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-002	9006224	2028-07-01	U-1681		2015-04-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-003	8410131	2025-11-01	U-1368		2013-04-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-003	8410131*PED	2026-05-01		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-003	9006224	2028-07-01	U-1681		2015-04-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-004	8410131	2025-11-01	U-1368		2013-04-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-004	8410131*PED	2026-05-01		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022334-004	9006224	2028-07-01	U-1681		2015-04-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022334-001	8410131	2025-11-01	U-1368		2013-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-001	8410131*PED	2026-05-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-001	9006224	2028-07-01	U-1681		2015-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-002	8410131	2025-11-01	U-1368		2013-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-002	8410131*PED	2026-05-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-002	9006224	2028-07-01	U-1681		2015-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-003	8410131	2025-11-01	U-1368		2013-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-003	8410131*PED	2026-05-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-003	9006224	2028-07-01	U-1681		2015-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-004	8410131	2025-11-01	U-1368		2013-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-004	8410131*PED	2026-05-01		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022334-004	9006224	2028-07-01	U-1681		2015-04-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022334-001	8410131	2025-11-01	U-1368		2013-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-001	8410131*PED	2026-05-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-001	9006224	2028-07-01	U-1681		2015-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-002	8410131	2025-11-01	U-1368		2013-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-002	8410131*PED	2026-05-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-002	9006224	2028-07-01	U-1681		2015-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-003	8410131	2025-11-01	U-1368		2013-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-003	8410131*PED	2026-05-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-003	9006224	2028-07-01	U-1681		2015-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-004	8410131	2025-11-01	U-1368		2013-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-004	8410131*PED	2026-05-01		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022334-004	9006224	2028-07-01	U-1681		2015-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022334-001	8410131	2025-11-01	U-1368		2013-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-001	8410131*PED	2026-05-01		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-001	9006224	2028-07-01	U-1681		2015-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022334-002	8410131	2025-11-01	U-1368		2013-04-02	`011fe1cb6892…`

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
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022334-001	ODE-108	2023-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022334-002	ODE-108	2023-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022334-003	ODE-108	2023-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022334-004	ODE-108	2023-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022334-001	ODE-108	2023-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022334-002	ODE-108	2023-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022334-003	ODE-108	2023-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022334-004	ODE-108	2023-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022334-001	ODE-108	2023-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022334-002	ODE-108	2023-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022334-003	ODE-108	2023-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022334-004	ODE-108	2023-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022334-001	I-724	2019-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-001	ODE-24	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-001	PED	2019-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-001	ODE-108	2023-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-002	I-724	2019-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-002	ODE-24	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-002	PED	2019-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-002	ODE-108	2023-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-003	I-724	2019-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-003	ODE-24	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-003	PED	2019-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-003	ODE-108	2023-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-004	I-724	2019-02-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-004	ODE-24	2019-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-004	PED	2019-10-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022334-004	ODE-108	2023-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022334-001	ODE-108	2023-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022334-002	ODE-108	2023-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022334-003	ODE-108	2023-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022334-004	ODE-108	2023-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022334-001	ODE-108	2023-02-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022334-002	ODE-108	2023-02-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022334-003	ODE-108	2023-02-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022334-004	ODE-108	2023-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022334-001	ODE-108	2023-02-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022334-002	ODE-108	2023-02-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022334-003	ODE-108	2023-02-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022334-004	ODE-108	2023-02-26	`87673890dc5c…`

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: Afinitor
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EVEROLIMUS	5 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
0078-0566-51	Afinitor	28 in 1 CARTON	TABLET	28		66
0078-0566-61	Afinitor	1 in 1 BLISTER PACK	TABLET	1		66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0566-51	EA - Each	0078-0566	8a5d0e0f-98ab-4057-b7bd-b126f56fb393	1	2012-07-24
0078-0566-61	EA - Each	0078-0566	70663843-38e5-498e-8538-9e129a808f94	1	2012-07-24

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
0078-0566	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): 022334 application number: NDA022334 ndc (product): 0078-0566

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
0078-0566-51	00078056651	28 BLISTER PACK in 1 CARTON (0078-0566-51) / 1 TABLET in 1 BLISTER PACK (0078-0566-61)	28 blister pack	2009-03-31	0000-00-00	No	No	Current
0078-0566-61	00078056661	1 in 1 BLISTER PACK						Historical