Home NDC 65897-0010 Tacrolimus
Product NDC 65897-0010
11-digit product format 658970010
Labeler code 65897
Product ID 65897-0010_39a2918e-2da4-a843-e063-6294a90a9fec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form CAPSULE
Route ORAL
Labeler Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd
Application ANDA210929
Marketing category ANDA
Marketing start 2025-07-11
Substance TACROLIMUS ANHYDROUS
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 A210929-001 TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL 2023-04-17 A210929-002 TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE / ORAL 2023-04-17 A210929-003 TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE / ORAL 2023-04-17
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 · 69 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 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL 2023-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL 2023-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL 2023-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL 2023-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL 2023-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL 2023-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL 2023-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL 2023-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL 2023-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL 2023-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL 2023-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL 2023-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2023-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2023-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2023-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2023-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2023-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2023-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2023-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2023-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2023-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2023-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2023-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2023-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2023-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2023-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2023-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2023-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2023-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2023-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2023-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2023-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2023-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2023-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2023-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2023-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2023-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210929-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2023-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210929-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2023-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210929-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2023-04-17 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 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 ANHYDROUS 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y5L2157C4J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198377 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 65897-0010-2 Tacrolimus 1 in 1 CARTON CAPSULE 1 1 65897-0010-2 Tacrolimus 10 in 1 BAG CAPSULE 10 1
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 Tacrolimus TACROLIMUS Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd 759cf905-7406-4d1b-a1a8-10068cb11f04 2025-07-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210929 application number: ANDA210929 ndc (product): 65897-0010
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65897-0010-2 65897001002 1 BAG in 1 CARTON (65897-0010-2) / 10 BLISTER PACK in 1 BAG / 10 CAPSULE in 1 BLISTER PACK 1 bag 2025-07-11 No No Current