Home NDC 82009-164 Tacrolimus
Product NDC 82009-164
11-digit product format 820090164
Labeler code 82009
Product ID 82009-164_3e44dd25-4ad2-6ddc-f77b-7a66fc7fb89a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form CAPSULE
Route ORAL
Labeler Quallent Pharmaceuticals Health LLC
Application ANDA090509
Marketing category ANDA
Marketing start 2025-06-01
Substance TACROLIMUS
Active strength .5 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 1 .
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 A090509-001 TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 A090509-002 TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 A090509-003 TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090509-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-05-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090509-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090509-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-05-12 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 .5 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 82009-164-01 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 82009-164 TACROLIMUS CAPSULE [QUALLENT PHARMACEUTICALS HEALTH LLC] 3 Current NDC, 1 package rows 20250402_23b7b4d7-1431-e9f2-43ba-eabd169dc2dd.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tacrolimus TACROLIMUS Major Pharmaceuticals 0addf3f5-9bd5-4ef3-8c7f-52be20c16cf9 2026-05-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090509 application number: ANDA090509 Tacrolimus TACROLIMUS Quallent Pharmaceuticals Health LLC 23b7b4d7-1431-e9f2-43ba-eabd169dc2dd 2025-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090509 application number: ANDA090509 ndc (product): 82009-164 Tacrolimus TACROLIMUS American Health Packaging 93d03943-0655-44f6-b494-57bd1e336a34 2024-10-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090509 application number: ANDA090509 Tacrolimus TACROLIMUS Dr. Reddy's Laboratories Limited 61dee012-43af-0e9a-3843-9b9b91e022c4 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090509 application number: ANDA090509
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82009-164-01 82009016401 100 CAPSULE in 1 BOTTLE (82009-164-01) 100 capsule 2025-06-01 No No Current