Home NDC 0469-0607 Prograf
Product NDC 0469-0607
11-digit product format 004690607
Labeler code 0469
Product ID 0469-0607_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 1998-08-24
Substance TACROLIMUS
Active strength .5 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 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.
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.
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 .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 · 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0469-0607-73 Prograf 100 in 1 BOTTLE CAPSULE, GELATIN COATED 100 30 0469-0607-73 Prograf 1 in 1 CARTON CAPSULE, GELATIN COATED 1 30
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0469-0607 PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED PROGRAF (TACROLIMUS) INJECTION, SOLUTION PROGRAF (TACROLIMUS) GRANULE, FOR SUSPENSION [ASTELLAS PHARMA US, INC.] 30 Current NDC, Legacy NDC, 2 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 (product): 0469-0607
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0469-0607-73 00469060773 1 BOTTLE in 1 CARTON (0469-0607-73) / 100 CAPSULE, GELATIN COATED in 1 BOTTLE 1 bottle 1998-08-24 0000-00-00 No No Current