Envarsus

Product NDC: 68992-3010
11-digit product format: 689923010
Labeler code: 68992
Product ID: 68992-3010_163c129d-f4e2-484d-af96-c265c9a5e38c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Veloxis Pharmaceuticals, Inc
Application: NDA206406
Marketing category: NDA
Marketing start: 2015-09-01
Substance: TACROLIMUS
Active strength: 1 mg/1
Pharmacologic classes: Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin 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 43.

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
N206406-001	ENVARSUS XR	TACROLIMUS	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10
N206406-002	ENVARSUS XR	TACROLIMUS	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10
N206406-003	ENVARSUS XR	TACROLIMUS	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10

Orange Book patents#

Current patent rows page 1 of 1 · 45 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206406-001	10166190	2028-05-30		Drug product	2019-02-14
N206406-001	10864199	2028-05-30	U-2677		2021-01-06
N206406-001	10864199	2028-05-30	U-2678		2021-01-06
N206406-001	11110081	2028-05-30	U-2678		2021-09-16
N206406-001	11123331	2028-05-30	U-2677		2021-09-28
N206406-001	11419823	2028-05-30		Drug product	2022-08-24
N206406-001	12083103	2028-05-30	U-2678		2024-09-12
N206406-001	12403095	2028-05-30		Drug product	2025-09-08
N206406-001	9549918	2028-05-30		Drug product	2017-05-02
N206406-001	8664239	2028-08-30	U-1752		2015-08-24
N206406-001	8664239	2028-08-30	U-2677		2015-08-24
N206406-001	8664239	2028-08-30	U-2678		2015-08-24
N206406-001	8685998	2028-08-30	U-1752	Drug product	2015-08-24
N206406-001	8685998	2028-08-30	U-2677	Drug product	2015-08-24
N206406-001	8685998	2028-08-30	U-2678	Drug product	2015-08-24
N206406-002	10166190	2028-05-30		Drug product	2019-02-14
N206406-002	10864199	2028-05-30	U-2677		2021-01-06
N206406-002	10864199	2028-05-30	U-2678		2021-01-06
N206406-002	11110081	2028-05-30	U-2678		2021-09-16
N206406-002	11123331	2028-05-30	U-2677		2021-09-28
N206406-002	11419823	2028-05-30		Drug product	2022-08-24
N206406-002	12083103	2028-05-30	U-2678		2024-09-12
N206406-002	12403095	2028-05-30		Drug product	2025-09-08
N206406-002	9549918	2028-05-30		Drug product	2017-05-02
N206406-002	8664239	2028-08-30	U-1752		2015-08-24
N206406-002	8664239	2028-08-30	U-2677		2015-08-24
N206406-002	8664239	2028-08-30	U-2678		2015-08-24
N206406-002	8685998	2028-08-30	U-1752	Drug product	2015-08-24
N206406-002	8685998	2028-08-30	U-2677	Drug product	2015-08-24
N206406-002	8685998	2028-08-30	U-2678	Drug product	2015-08-24
N206406-003	10166190	2028-05-30		Drug product	2019-02-14
N206406-003	10864199	2028-05-30	U-2677		2021-01-06
N206406-003	10864199	2028-05-30	U-2678		2021-01-06
N206406-003	11110081	2028-05-30	U-2678		2021-09-16
N206406-003	11123331	2028-05-30	U-2677		2021-09-28
N206406-003	11419823	2028-05-30		Drug product	2022-08-24
N206406-003	12083103	2028-05-30	U-2678		2024-09-12
N206406-003	12403095	2028-05-30		Drug product	2025-09-08
N206406-003	9549918	2028-05-30		Drug product	2017-05-02
N206406-003	8664239	2028-08-30	U-1752		2015-08-24
N206406-003	8664239	2028-08-30	U-2677		2015-08-24
N206406-003	8664239	2028-08-30	U-2678		2015-08-24
N206406-003	8685998	2028-08-30	U-1752	Drug product	2015-08-24
N206406-003	8685998	2028-08-30	U-2677	Drug product	2015-08-24
N206406-003	8685998	2028-08-30	U-2678	Drug product	2015-08-24

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 77 · 3,063 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206406-001	10166190	2028-05-30		Drug product	2019-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	10864199	2028-05-30	U-2678		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	10864199	2028-05-30	U-2677		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	11110081	2028-05-30	U-2678		2021-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	11123331	2028-05-30	U-2677		2021-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	11419823	2028-05-30		Drug product	2022-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	12083103	2028-05-30	U-2678		2024-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	12403095	2028-05-30		Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	9549918	2028-05-30		Drug product	2017-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8664239	2028-08-30	U-1752		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8664239	2028-08-30	U-2677		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8664239	2028-08-30	U-2678		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8685998	2028-08-30	U-1752	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8685998	2028-08-30	U-2678	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8685998	2028-08-30	U-2677	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	10166190	2028-05-30		Drug product	2019-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	10864199	2028-05-30	U-2677		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	10864199	2028-05-30	U-2678		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	11110081	2028-05-30	U-2678		2021-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	11123331	2028-05-30	U-2677		2021-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	11419823	2028-05-30		Drug product	2022-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	12083103	2028-05-30	U-2678		2024-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	12403095	2028-05-30		Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	9549918	2028-05-30		Drug product	2017-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8664239	2028-08-30	U-1752		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8664239	2028-08-30	U-2677		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8664239	2028-08-30	U-2678		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8685998	2028-08-30	U-1752	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8685998	2028-08-30	U-2678	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8685998	2028-08-30	U-2677	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	10166190	2028-05-30		Drug product	2019-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	10864199	2028-05-30	U-2677		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	10864199	2028-05-30	U-2678		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	11110081	2028-05-30	U-2678		2021-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	11123331	2028-05-30	U-2677		2021-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	11419823	2028-05-30		Drug product	2022-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	12083103	2028-05-30	U-2678		2024-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	12403095	2028-05-30		Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	9549918	2028-05-30		Drug product	2017-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	8664239	2028-08-30	U-1752		2015-08-24	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 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	N206406-001	ODE-94	2022-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206406-002	ODE-94	2022-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206406-003	ODE-94	2022-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206406-001	ODE-94	2022-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206406-002	ODE-94	2022-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206406-003	ODE-94	2022-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206406-001	ODE-94	2022-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206406-002	ODE-94	2022-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206406-003	ODE-94	2022-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206406-001	ODE-94	2022-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206406-002	ODE-94	2022-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206406-003	ODE-94	2022-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206406-001	ODE-94	2022-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206406-002	ODE-94	2022-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206406-003	ODE-94	2022-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206406-001	ODE-94	2022-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206406-002	ODE-94	2022-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206406-003	ODE-94	2022-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206406-001	ODE-94	2022-07-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206406-002	ODE-94	2022-07-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206406-003	ODE-94	2022-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206406-001	ODE-94	2022-07-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206406-002	ODE-94	2022-07-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206406-003	ODE-94	2022-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206406-001	ODE-94	2022-07-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206406-002	ODE-94	2022-07-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206406-003	ODE-94	2022-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206406-001	ODE-94	2022-07-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206406-002	ODE-94	2022-07-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206406-003	ODE-94	2022-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206406-001	ODE-94	2022-07-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206406-002	ODE-94	2022-07-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206406-003	ODE-94	2022-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206406-001	ODE-94	2022-07-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206406-002	ODE-94	2022-07-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206406-003	ODE-94	2022-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206406-001	ODE-94	2022-07-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206406-002	ODE-94	2022-07-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206406-003	ODE-94	2022-07-10	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N206406-001	ODE-94	2022-07-10	`3bdfa0b2c4d7…`

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: Envarsus
Brand name suffix: XR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TACROLIMUS	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WM0HAQ4WNM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1664434	Internal RxNorm lookup
1664440	Internal RxNorm lookup
1664456	Internal RxNorm lookup
1664458	Internal RxNorm lookup
1664461	Internal RxNorm lookup
1664463	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
de2315b0-6344-43ac-9aea-3e3b68d828e7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
df369ad4-19d8-393a-de46-8c6255b8b360	Product name	8	20251120
d2a74186-7b26-dbcc-9435-50b3d0be14ab	Product name	2	20250114
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
a64835ae-fa9d-41d8-9a93-36828ba72b96	Product name	3	20190611
b4a869e4-9fcd-47bd-95e3-85e7c75f8bad	Product name	1	20150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68992-3010-1	EnvarsusXR	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	16
68992-3010-1	EnvarsusXR	1 in 1 POUCH	TABLET, EXTENDED RELEASE	1	16
68992-3010-3	EnvarsusXR	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	16
68992-3010-3	EnvarsusXR	1 in 1 POUCH	TABLET, EXTENDED RELEASE	1	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68992-3010-1	EA - Each	68992-3010	76fc7e59-40d0-46e5-830d-4d8f42212c5c	1	2015-10-02
68992-3010-3	EA - Each	68992-3010	ebb67c30-544f-4996-bd2e-3df502752965	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TACROLIMUS	ACTIVE INGREDIENT	WM0HAQ4WNM	ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]	3
TACROLIMUS ANHYDROUS	ACTIVE MOIETY	Y5L2157C4J	ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]	3
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]	3
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]	3
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68992-3010	ENVARSUS XR (TACROLIMUS) TABLET, EXTENDED RELEASE [VELOXIS PHARMACEUTICALS, INC]	16	Current NDC, Legacy NDC, 4 package rows	20250302_de2315b0-6344-43ac-9aea-3e3b68d828e7.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
Envarsus XR	TACROLIMUS	Veloxis Pharmaceuticals, Inc	de2315b0-6344-43ac-9aea-3e3b68d828e7	2025-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 206406 application number: NDA206406 ndc (product): 68992-3010

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WM0HAQ4WNM	TACROLIMUS	109581-93-3	TACROLIMUS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1664458	Envarsus XR 0.75 MG 24HR Extended Release Oral Tablet	PSN	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664463	Envarsus XR 1 MG 24HR Extended Release Oral Tablet	PSN	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664440	Envarsus XR 4 MG 24HR Extended Release Oral Tablet	PSN	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664456	tacrolimus 0.75 MG 24HR Extended Release Oral Tablet	PSN	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664461	tacrolimus 1 MG 24HR Extended Release Oral Tablet	PSN	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664434	tacrolimus 4 MG 24HR Extended Release Tablet	PSN	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664458	24 HR tacrolimus 0.75 MG Extended Release Oral Tablet [Envarsus]	SBD	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664463	24 HR tacrolimus 1 MG Extended Release Oral Tablet [Envarsus]	SBD	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664440	24 HR tacrolimus 4 MG Extended Release Oral Tablet [Envarsus]	SBD	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664456	24 HR tacrolimus 0.75 MG Extended Release Oral Tablet	SCD	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664461	24 HR tacrolimus 1 MG Extended Release Oral Tablet	SCD	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664434	24 HR tacrolimus 4 MG Extended Release Oral Tablet	SCD	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664458	24 HR Envarsus 0.75 MG Extended Release Oral Tablet	SY	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664463	24 HR Envarsus 1 MG Extended Release Oral Tablet	SY	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664440	24 HR Envarsus 4 MG Extended Release Oral Tablet	SY	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664458	Envarsus XR 0.75 MG 24HR Extended Release Oral Tablet	SY	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664463	Envarsus XR 1 MG 24HR Extended Release Oral Tablet	SY	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664440	Envarsus XR 4 MG 24HR Extended Release Oral Tablet	SY	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664456	tacrolimus 0.75 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Tablet	SY	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664461	tacrolimus 1 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Tablet	SY	de2315b0-6344-43ac-9aea-3e3b68d828e7	16
1664434	tacrolimus 4 MG (as anhydrous tacrolimus) 24HR Extended Release Tablet	SY	de2315b0-6344-43ac-9aea-3e3b68d828e7	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68992-3010-1	68992301001	1 POUCH in 1 CARTON (68992-3010-1) / 1 BOTTLE in 1 POUCH / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE	1 pouch	2015-09-01	0000-00-00	No	No	Current
68992-3010-3	68992301003	1 POUCH in 1 CARTON (68992-3010-3) / 1 BOTTLE, PLASTIC in 1 POUCH / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC	1 pouch	2015-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Envarsus XR	Veloxis Pharmaceuticals, Inc \| Rottendorf Pharma GmbH \| Pharma Packaging Solutions, LLC dba Tjoapack, LLC	2025-02-26	HUMAN PRESCRIPTION DRUG LABEL	16