Home NDC 82983-401 Tacrolimus
Product NDC 82983-401
11-digit product format 829830401
Labeler code 82983
Product ID 82983-401_6b08720e-dc88-4731-8863-af564a293b5a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form CAPSULE
Route ORAL
Labeler Ajenat Pharmaceuticals LLC
Application ANDA206651
Marketing category ANDA
Marketing start 2023-01-31
Substance TACROLIMUS
Active strength 1 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 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 · 6 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 2025-02-02 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 82983-401-10 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 82983-401-10 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 82983-401-10 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A206651-001 TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 A206651-002 TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 A206651-003 TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30
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 · 129 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 2026-09-14 22:38:34 2026-08 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206651-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2017-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206651-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2017-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206651-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2017-11-30 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tacrolimus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TACROLIMUS 1 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198377 Internal RxNorm lookup 198378 Internal RxNorm lookup 313190 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 82983-401-10 Tacrolimus 100 in 1 BOTTLE CAPSULE 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82983-401 TACROLIMUS CAPSULE [AJENAT PHARMACEUTICALS LLC] 2 Current NDC, 1 package rows 20250213_ca08d4aa-3de2-4a9d-9554-6288e5d36f29.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82983-401-10 82983040110 100 CAPSULE in 1 BOTTLE (82983-401-10) 100 capsule 2023-01-31 No No Current