Prograf

Product NDC: 43353-178
11-digit product format: 433530178
Labeler code: 43353
Product ID: 43353-178_b0d8a6ff-5163-4f29-abcd-8318b92bbef9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tacrolimus
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA050708
Marketing category: NDA
Marketing start: 1994-04-08
Marketing end: 0000-00-00
Substance: TACROLIMUS
Active strength: 1 mg/1
Pharmacologic classes: Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-178		I	Inactivated by FDA	2026-10-16
excluded package	package	43353-178	43353-178-09	I	Inactivated by FDA	2026-10-16
excluded package	package	43353-178	43353-178-53	I	Inactivated by FDA	2026-10-16
excluded package	package	43353-178	43353-178-60	I	Inactivated by FDA	2026-10-16
excluded package	package	43353-178	43353-178-80	I	Inactivated by FDA	2026-10-16

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 2 · 105 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-178-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-178-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-178-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-178-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-178-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-178-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-178-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-178-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-178-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-178-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-178-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-178-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-178-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-178-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-178-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-178-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-178-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-178-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-178-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-178-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-178-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-178-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-178-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-178-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-178-53	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-178-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-178-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-178-09	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-178-53	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-178-80	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-178-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-178-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-178-53	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-178-80	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-178-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-178-09	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-178-53	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-178-80	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-178-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-178-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-178-53	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-178-80	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-178-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-178-09	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-178-53	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-178-80	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-178-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-178-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 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	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 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	N050708-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050708-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050708-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050708-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050708-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050708-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050708-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050708-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050708-003	AB	1	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 6 · 213 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-001	ODE-360	2028-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-002	ODE-294	2025-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-002	ODE-360	2028-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-003	ODE-294	2025-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-003	ODE-360	2028-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-001	ODE-294	2025-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-001	ODE-360	2028-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-002	ODE-294	2025-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-002	ODE-360	2028-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-003	ODE-294	2025-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-003	ODE-360	2028-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050708-001	ODE-294	2025-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050708-001	ODE-360	2028-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050708-002	ODE-294	2025-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050708-002	ODE-360	2028-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050708-003	ODE-294	2025-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050708-003	ODE-360	2028-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-001	ODE-294	2025-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-001	ODE-360	2028-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-002	ODE-294	2025-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-002	ODE-360	2028-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-003	ODE-294	2025-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-003	ODE-360	2028-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-001	ODE-294	2025-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-001	ODE-360	2028-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-002	ODE-294	2025-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-002	ODE-360	2028-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-003	ODE-294	2025-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050708-003	ODE-360	2028-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050708-001	ODE-294	2025-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050708-001	ODE-360	2028-07-16	`1e350fbaab3a…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-178-09	These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF ® (tacrolimus) capsules, USP PROGRAF ® (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994
43353-178-53	These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF ® (tacrolimus) capsules, USP PROGRAF ® (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994
43353-178-60	These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF ® (tacrolimus) capsules, USP PROGRAF ® (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994
43353-178-80	These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF ® (tacrolimus) capsules, USP PROGRAF ® (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-178-09	Prograf	9000 in 1 BOTTLE, PLASTIC	CAPSULE, GELATIN COATED	9000	1
43353-178-53	Prograf	60 in 1 BOTTLE, PLASTIC	CAPSULE, GELATIN COATED	60	1
43353-178-60	Prograf	90 in 1 BOTTLE, PLASTIC	CAPSULE, GELATIN COATED	90	1
43353-178-80	Prograf	180 in 1 BOTTLE, PLASTIC	CAPSULE, GELATIN COATED	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-178-09	EA - Each	43353-178	7f2eb294-48d8-44eb-b561-ebfeac9a3745	1	2015-01-05
43353-178-53	EA - Each	43353-178	ad5a497b-d441-4f93-a3d3-90d5fea6d599	1	2014-06-03
43353-178-60	EA - Each	43353-178	047a2dd3-c71c-49cc-8e23-8d841f5e6e42	1	2014-06-03
43353-178-80	EA - Each	43353-178	f78efd79-1d4e-4164-9429-47ae85d9a653	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
TACROLIMUS	ACTIVE INGREDIENT	WM0HAQ4WNM	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TACROLIMUS ANHYDROUS	ACTIVE MOIETY	Y5L2157C4J	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-178	PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 4 package rows	20140521_1e56c550-1c2b-4177-8e49-26303e9e335f.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

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
108513	Prograf 1 MG Oral Capsule	PSN	1e56c550-1c2b-4177-8e49-26303e9e335f	1
198377	tacrolimus 1 MG Oral Capsule	PSN	1e56c550-1c2b-4177-8e49-26303e9e335f	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
108513	Prograf 1 MG Oral Capsule	SY	1e56c550-1c2b-4177-8e49-26303e9e335f	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	Status
43353-178-09	43353017809	9000 in 1 BOTTLE, PLASTIC	Historical
43353-178-53	43353017853	60 in 1 BOTTLE, PLASTIC	Historical
43353-178-60	43353017860	90 in 1 BOTTLE, PLASTIC	Historical
43353-178-80	43353017880	180 in 1 BOTTLE, PLASTIC	Historical