Home NDC 69452-154-20 Tacrolimus
Product NDC 69452-154
Requested package NDC 69452-154-20
11-digit product format 694520154
Labeler code 69452
Product ID 69452-154_b748f1a3-f852-4326-e053-2995a90ac2c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler BionPharma Inc.,
Application ANDA090802
Marketing category ANDA
Marketing start 2016-02-26
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 2021-12-31
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 · 9 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…
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 A090802-001 TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 A090802-002 TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 A090802-003 TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090802-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2012-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090802-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2012-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090802-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2012-09-28 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69452-154-20 69452015420 100 CAPSULE, GELATIN COATED in 1 BOTTLE (69452-154-20) 2016-02-26 0000-00-00 No No Current