Prograf

Product NDC: 0469-0617
Requested package NDC: 0469-0617-11
11-digit product format: 004690617
Labeler code: 0469
Product ID: 0469-0617_e9157663-1515-4ba3-83b5-1622cf6f0f99
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Astellas Pharma US, Inc.
Application: NDA050708
Marketing category: NDA
Marketing start: 1994-04-08
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

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	0469-0617	0469-0617-11	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N050708-001	PROGRAF	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08
N050708-002	PROGRAF	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08
N050708-003	PROGRAF	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050708-001	AB
N050708-002	AB
N050708-003	AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N050708-001	ODE-360	2028-07-16
N050708-002	ODE-360	2028-07-16
N050708-003	ODE-360	2028-07-16

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	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N050708-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050708-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050708-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050708-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050708-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050708-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050708-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050708-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050708-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050708-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050708-001	AB	1	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050708-001	ODE-360	2028-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050708-002	ODE-360	2028-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050708-003	ODE-360	2028-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-001	ODE-294	2025-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-001	ODE-360	2028-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-002	ODE-294	2025-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-002	ODE-360	2028-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-003	ODE-294	2025-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-003	ODE-360	2028-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050708-001	ODE-294	2025-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-001	ODE-360	2028-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-002	ODE-294	2025-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-002	ODE-360	2028-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-003	ODE-294	2025-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-003	ODE-360	2028-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-001	ODE-294	2025-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-001	ODE-360	2028-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-002	ODE-294	2025-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-002	ODE-360	2028-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-003	ODE-294	2025-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-003	ODE-360	2028-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-001	ODE-294	2025-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-001	ODE-360	2028-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-002	ODE-294	2025-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-002	ODE-360	2028-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-003	ODE-294	2025-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-003	ODE-360	2028-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-001	ODE-294	2025-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-001	ODE-360	2028-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-002	ODE-294	2025-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-002	ODE-360	2028-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-003	ODE-294	2025-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-003	ODE-360	2028-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-001	ODE-294	2025-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-001	ODE-360	2028-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-002	ODE-294	2025-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-002	ODE-360	2028-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-003	ODE-294	2025-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-003	ODE-360	2028-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-001	ODE-294	2025-05-24	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Prograf
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 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
108513	Internal RxNorm lookup
108514	Internal RxNorm lookup
108515	Internal RxNorm lookup
198377	Internal RxNorm lookup
198378	Internal RxNorm lookup
198379	Internal RxNorm lookup
261134	Internal RxNorm lookup
313190	Internal RxNorm lookup
2052605	Internal RxNorm lookup
2052609	Internal RxNorm lookup
2052703	Internal RxNorm lookup
2052704	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
7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	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
0469-0617-11	Prograf	10 in 1 CARTON	CAPSULE, GELATIN COATED	10	30
0469-0617-11	Prograf	10 in 1 BLISTER PACK	CAPSULE, GELATIN COATED	10	30
0469-0617-73	Prograf	1 in 1 CARTON	CAPSULE, GELATIN COATED	1	30
0469-0617-73	Prograf	100 in 1 BOTTLE	CAPSULE, GELATIN COATED	100	30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0469-0617-11	EA - Each	0469-0617	3c369541-d412-4f6c-9d33-f5cd69f77237	1	2012-07-24
0469-0617-73	EA - Each	0469-0617	13e74cbb-857f-46b9-87cf-988615f0d6fe	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TACROLIMUS	ACTIVE INGREDIENT	WM0HAQ4WNM	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION [ASTELLAS PHARMA US, INC.]	15
TACROLIMUS ANHYDROUS	ACTIVE MOIETY	Y5L2157C4J	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION [ASTELLAS PHARMA US, INC.]	15
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION [ASTELLAS PHARMA US, INC.]	15
PEG-60 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	02NG325BQG	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION [ASTELLAS PHARMA US, INC.]	15
anhydrous tacrolimus	ACTIVE INGREDIENT	Y5L2157C4J	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
TACROLIMUS	ACTIVE INGREDIENT	WM0HAQ4WNM	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
tacrolimus	ACTIVE MOIETY	WM0HAQ4WNM	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
TACROLIMUS ANHYDROUS	ACTIVE MOIETY	Y5L2157C4J	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0469-0617	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION PROGRAF (TACROLIMUS) GRANULE, FOR SUSPENSION [ASTELLAS PHARMA US, INC.]	30	Current NDC, Legacy NDC, 4 package rows	20250321_7f667de1-9dfa-4bd6-8ba0-15ee2d78873b.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
Prograf	TACROLIMUS	Astellas Pharma US, Inc.	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	2023-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050708 application number: NDA050708 ndc (package): 0469-0617-11 ndc (product): 0469-0617 ndc11 (package): 00469061711

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
2052609	Prograf 0.2 MG Granules for Oral Suspension	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
261134	Prograf 0.5 MG Oral Capsule	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
2052704	Prograf 1 MG Granules for Oral Suspension	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
108513	Prograf 1 MG Oral Capsule	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
108515	Prograf 5 MG in 1 ML Injection	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
108514	Prograf 5 MG Oral Capsule	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
2052605	tacrolimus 0.2 MG Granules for Oral Suspension	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
313190	tacrolimus 0.5 MG Oral Capsule	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
2052703	tacrolimus 1 MG Granules for Oral Suspension	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
198377	tacrolimus 1 MG Oral Capsule	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
198379	tacrolimus 5 MG in 1 ML Injection	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
198378	tacrolimus 5 MG Oral Capsule	PSN	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
108515	1 ML tacrolimus 5 MG/ML Injection [Prograf]	SBD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
2052609	tacrolimus 0.2 MG Granules for Oral Suspension [Prograf]	SBD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
261134	tacrolimus 0.5 MG Oral Capsule [Prograf]	SBD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
2052704	tacrolimus 1 MG Granules for Oral Suspension [Prograf]	SBD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
108513	tacrolimus 1 MG Oral Capsule [Prograf]	SBD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
108514	tacrolimus 5 MG Oral Capsule [Prograf]	SBD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
198379	1 ML tacrolimus 5 MG/ML Injection	SCD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
2052605	tacrolimus 0.2 MG Granules for Oral Suspension	SCD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
313190	tacrolimus 0.5 MG Oral Capsule	SCD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
2052703	tacrolimus 1 MG Granules for Oral Suspension	SCD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
198377	tacrolimus 1 MG Oral Capsule	SCD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
198378	tacrolimus 5 MG Oral Capsule	SCD	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
2052609	Prograf 0.2 MG Granules for Oral Suspension	SY	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
261134	Prograf 0.5 MG Oral Capsule	SY	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
2052704	Prograf 1 MG Granules for Oral Suspension	SY	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
108513	Prograf 1 MG Oral Capsule	SY	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
108514	Prograf 5 MG Oral Capsule	SY	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
108515	Prograf 5 MG per 1 ML Injection	SY	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
313190	tacrolimus 0.5 MG (as anhydrous tacrolimus) Oral Capsule	SY	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
198378	tacrolimus 5 MG (as anhydrous tacrolimus) Oral Capsule	SY	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
198379	tacrolimus 5 MG per 1 ML Injection	SY	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	30
108513	Prograf 1 MG Oral Capsule	PSN	1e56c550-1c2b-4177-8e49-26303e9e335f	1
108513	Prograf 1 MG Oral Capsule	PSN	f15b043d-fcfa-4ade-a3da-76700c0c5c2a	1
198377	tacrolimus 1 MG Oral Capsule	PSN	1e56c550-1c2b-4177-8e49-26303e9e335f	1
198377	tacrolimus 1 MG Oral Capsule	PSN	f15b043d-fcfa-4ade-a3da-76700c0c5c2a	1
108513	tacrolimus 1 MG Oral Capsule [Prograf]	SBD	f15b043d-fcfa-4ade-a3da-76700c0c5c2a	1
108513	tacrolimus 1 MG Oral Capsule [Prograf]	SBD	1e56c550-1c2b-4177-8e49-26303e9e335f	1
198377	tacrolimus 1 MG Oral Capsule	SCD	1e56c550-1c2b-4177-8e49-26303e9e335f	1
198377	tacrolimus 1 MG Oral Capsule	SCD	f15b043d-fcfa-4ade-a3da-76700c0c5c2a	1
108513	Prograf 1 MG Oral Capsule	SY	f15b043d-fcfa-4ade-a3da-76700c0c5c2a	1
108513	Prograf 1 MG Oral Capsule	SY	1e56c550-1c2b-4177-8e49-26303e9e335f	1
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	f15b043d-fcfa-4ade-a3da-76700c0c5c2a	1
198377	tacrolimus 1 MG (as anhydrous tacrolimus) Oral Capsule	SY	1e56c550-1c2b-4177-8e49-26303e9e335f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0469-0617-11	00469061711	10 BLISTER PACK in 1 CARTON (0469-0617-11) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK	10 blister pack	1994-04-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prograf	Astellas Pharma US, Inc.	2023-08-25	HUMAN PRESCRIPTION DRUG LABEL	30
Prograf	Aphena Pharma Solutions - Tennessee, LLC	2014-05-20	HUMAN PRESCRIPTION DRUG LABEL	1
PROGRAF® tacrolimus capsules tacrolimus injection (for intravenous infusion only)	Rebel Distributors Corp	2010-12-28	HUMAN PRESCRIPTION DRUG LABEL	1