Home NDC 0469-3016 Prograf
Product NDC 0469-3016
11-digit product format 004693016
Labeler code 0469
Product ID 0469-3016_e9157663-1515-4ba3-83b5-1622cf6f0f99
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Astellas Pharma US, Inc.
Application NDA050709
Marketing category NDA
Marketing start 1994-04-08
Substance TACROLIMUS
Active strength 5 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050709-001 PROGRAF TACROLIMUS EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050709-001 AP
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N050709-001 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 2 · 41 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 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION RLD, RS 1994-04-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050709-001 PROGRAF EQ 5MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1994-04-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 68 observed states.
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/mL
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 0469-3016-01 Prograf 1 mL in 1 AMPULE INJECTION, SOLUTION 1 30 0469-3016-01 Prograf 10 in 1 BOX INJECTION, SOLUTION 10 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 0469-3016 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): 050709 application number: NDA050709 ndc (product): 0469-3016
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 0469-3016-01 00469301601 10 AMPULE in 1 BOX (0469-3016-01) / 1 mL in 1 AMPULE 10 ampule 1994-04-08 0000-00-00 No No Current