ASTAGRAF XL

Product NDC: 0469-0647
11-digit product format: 004690647
Labeler code: 0469
Product ID: 0469-0647_4ecfe626-bf9c-4889-a1d4-64b03d60eaf8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tacrolimus extended-release capsules
Dosage form: CAPSULE, COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Astellas Pharma US, Inc.
Application: NDA204096
Marketing category: NDA
Marketing start: 2013-07-19
Substance: TACROLIMUS
Active strength: .5 mg/1
Pharmacologic classes: Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0469-0647	0469-0647-11	D	Discontinued by firm		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204096-001	ASTAGRAF XL	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19
N204096-002	ASTAGRAF XL	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19
N204096-003	ASTAGRAF XL	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204096-001	AB
N204096-002	AB
N204096-003	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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204096-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204096-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204096-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204096-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204096-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204096-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204096-001	6440458	2019-03-25		Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-001	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-001	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-001	8551522	2019-03-25		Drug product	2013-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-002	6440458	2019-03-25		Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-002	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-002	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-002	8551522	2019-03-25		Drug product	2013-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-003	6440458	2019-03-25		Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-003	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-003	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-003	8551522	2019-03-25		Drug product	2013-11-06	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N204096-001	6440458	2019-03-25		Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-001	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-001	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-001	8551522	2019-03-25		Drug product	2013-11-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-002	6440458	2019-03-25		Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-002	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-002	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-002	8551522	2019-03-25		Drug product	2013-11-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-003	6440458	2019-03-25		Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-003	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-003	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-003	8551522	2019-03-25		Drug product	2013-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204096-001	6440458	2019-03-25		Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-001	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-001	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-001	8551522	2019-03-25		Drug product	2013-11-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-002	6440458	2019-03-25		Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-002	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-002	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-002	8551522	2019-03-25		Drug product	2013-11-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-003	6440458	2019-03-25		Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-003	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-003	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-003	8551522	2019-03-25		Drug product	2013-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204096-001	6440458	2019-03-25		Drug product	2013-07-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204096-001	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204096-001	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204096-001	8551522	2019-03-25		Drug product	2013-11-06	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 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	N204096-001	ODE*	2025-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-002	ODE*	2025-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-003	ODE*	2025-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204096-001	ODE*	2025-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-002	ODE*	2025-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-003	ODE*	2025-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-001	ODE*	2025-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-002	ODE*	2025-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-003	ODE*	2025-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-001	ODE*	2025-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-002	ODE*	2025-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-003	ODE*	2025-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-001	ODE*	2025-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-002	ODE*	2025-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-003	ODE*	2025-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-001	ODE*	2025-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-002	ODE*	2025-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-003	ODE*	2025-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-001	ODE*	2025-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-002	ODE*	2025-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-003	ODE*	2025-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-001	ODE*	2025-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-002	ODE*	2025-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-003	ODE*	2025-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204096-001	ODE*	2025-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-002	ODE*	2025-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-003	ODE*	2025-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-001	ODE*	2025-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-002	ODE*	2025-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-003	ODE*	2025-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-001	ODE*	2025-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-002	ODE*	2025-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-003	ODE*	2025-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-001	ODE*	2025-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-002	ODE*	2025-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-003	ODE*	2025-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204096-001	ODE*	2025-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204096-002	ODE*	2025-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204096-003	ODE*	2025-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204096-001	ODE*	2025-05-24	`5c6f7cd8ea54…`

Additional Listing Data#

Finished product: Yes
Brand name base: ASTAGRAF XL
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TACROLIMUS	.5 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
1431971	Internal RxNorm lookup
1431977	Internal RxNorm lookup
1431980	Internal RxNorm lookup
1431982	Internal RxNorm lookup
1431985	Internal RxNorm lookup
1431987	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
550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	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
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
0469-0647-11	ASTAGRAF XL	10 in 1 BLISTER PACK	CAPSULE, COATED, EXTENDED RELEAS	10	12
0469-0647-11	ASTAGRAF XL	5 in 1 CARTON	CAPSULE, COATED, EXTENDED RELEAS	5	12
0469-0647-73	ASTAGRAF XL	1 in 1 CARTON	CAPSULE, COATED, EXTENDED RELEAS	1	12
0469-0647-73	ASTAGRAF XL	30 in 1 BOTTLE	CAPSULE, COATED, EXTENDED RELEAS	30	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0469-0647-73	EA - Each	0469-0647	a244a1bf-29f3-4305-87a2-63350ee7a88c	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
TACROLIMUS	ACTIVE INGREDIENT	WM0HAQ4WNM	ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES) CAPSULE, COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]	4
TACROLIMUS ANHYDROUS	ACTIVE MOIETY	Y5L2157C4J	ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES) CAPSULE, COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0469-0647	ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES) CAPSULE, COATED, EXTENDED RELEASE [ASTELLAS PHARMA US, INC.]	11	Current NDC, Legacy NDC, 4 package rows	20230927_550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e.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
ASTAGRAF XL	TACROLIMUS EXTENDED-RELEASE CAPSULES	Astellas Pharma US, Inc.	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204096 application number: NDA204096 ndc (product): 0469-0647

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
1431977	Astagraf XL 0.5 MG 24HR Extended Release Oral Capsule	PSN	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431982	Astagraf XL 1 MG 24HR Extended Release Oral Capsule	PSN	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431987	Astagraf XL 5 MG 24HR Extended Release Oral Capsule	PSN	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431971	tacrolimus 0.5 MG 24HR Extended Release Oral Capsule	PSN	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431980	tacrolimus 1 MG 24HR Extended Release Oral Capsule	PSN	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431985	tacrolimus 5 MG 24HR Extended Release Oral Capsule	PSN	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431977	24 HR tacrolimus 0.5 MG Extended Release Oral Capsule [Astagraf]	SBD	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431982	24 HR tacrolimus 1 MG Extended Release Oral Capsule [Astagraf]	SBD	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431987	24 HR tacrolimus 5 MG Extended Release Oral Capsule [Astagraf]	SBD	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431971	24 HR tacrolimus 0.5 MG Extended Release Oral Capsule	SCD	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431980	24 HR tacrolimus 1 MG Extended Release Oral Capsule	SCD	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431985	24 HR tacrolimus 5 MG Extended Release Oral Capsule	SCD	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431977	24 HR Astagraf 0.5 MG Extended Release Oral Capsule	SY	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431982	24 HR Astagraf 1 MG Extended Release Oral Capsule	SY	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431987	24 HR Astagraf 5 MG Extended Release Oral Capsule	SY	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431977	Astagraf XL 0.5 MG 24 HR Extended Release Oral Capsule	SY	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431982	Astagraf XL 1 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule	SY	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431982	Astagraf XL 1 MG 24 HR Extended Release Oral Capsule	SY	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431987	Astagraf XL 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule	SY	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431987	Astagraf XL 5 MG 24 HR Extended Release Oral Capsule	SY	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431971	tacrolimus 0.5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule	SY	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431980	tacrolimus 1 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule	SY	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12
1431985	tacrolimus 5 MG (as anhydrous tacrolimus) 24 HR Extended Release Oral Capsule	SY	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0469-0647-11	00469064711	5 BLISTER PACK in 1 CARTON (0469-0647-11) > 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK	5 blister pack	2013-07-19	0000-00-00	No	No	Current
0469-0647-73	00469064773	1 BOTTLE in 1 CARTON (0469-0647-73) / 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE	1 bottle	2013-07-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tacrolimus extended-release capsules	Astellas Pharma US, Inc. \| Astellas Ireland Co., Ltd. \| Astellas Pharma Inc.	2026-01-14	HUMAN PRESCRIPTION DRUG LABEL	12