Home NDC 43817-422 Tacrolimus
Product NDC 43817-422
11-digit product format 438170422
Labeler code 43817
Product ID 43817-422_778cec6b-16f1-47b0-9c97-113ea026b5e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Panacea Biotec Limited
Application ANDA090802
Marketing category ANDA
Marketing start 2016-02-26
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 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.
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43817-422-01 Tacrolimus 100 in 1 BOTTLE CAPSULE, GELATIN COATED 100 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43817-422 TACROLIMUS CAPSULE, GELATIN COATED [PANACEA BIOTEC LIMITED] 14 Current NDC, Legacy NDC, 1 package rows 20241211_bd9fea26-0236-d437-c7df-4b7636210875.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 Marketing start Marketing end Sample Exclude flag Status 43817-422-01 43817042201 100 CAPSULE, GELATIN COATED in 1 BOTTLE (43817-422-01) 2016-02-26 0000-00-00 No No Current