Home NDC 21695-170 Prograf
Product NDC 21695-170
11-digit product format 216950170
Labeler code 21695
Product ID 21695-170_f15b043d-fcfa-4ade-a3da-76700c0c5c2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Rebel Distributors Corp
Application NDA050708
Marketing category NDA
Marketing start 1994-04-08
Marketing end 0000-00-00
Substance ANHYDROUS TACROLIMUS
Active strength 1 mg/1
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 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 21695-170-00 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 21695-170-00 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 21695-170-00 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 21695-170-00 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 21695-170-00 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 21695-170-00 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 21695-170-00 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 21695-170-00 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 21695-170-00 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 21695-170-00 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 21695-170-00 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 21695-170-00 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 21695-170-00 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 21695-170-00 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 21695-170-00 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 21695-170-00 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 21695-170-00 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 21695-170-00 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 21695-170-00 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 21695-170-00 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 21695-170-00 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 21695-170-00 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 126 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 2026-08-18 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…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 207 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21695-170-00 Prograf 1 in 1 CARTON CAPSULE, GELATIN COATED 1 1 21695-170-00 Prograf 100 in 1 BOTTLE CAPSULE, GELATIN COATED 100 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded anhydrous tacrolimus ACTIVE INGREDIENT Y5L2157C4J PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP] 1 tacrolimus ACTIVE MOIETY WM0HAQ4WNM PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP] 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 21695-170 PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 2 package rows 20110104_f15b043d-fcfa-4ade-a3da-76700c0c5c2a.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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-170-00 21695017000 1 in 1 CARTON Historical