Home NDC 43353-317 Tacrolimus
Product NDC 43353-317
11-digit product format 433530317
Labeler code 43353
Product ID 43353-317_815744b6-6096-4a89-8171-cdca95e10631
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA090596
Marketing category ANDA
Marketing start 2015-11-18
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 A090596-001 TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 A090596-002 TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 A090596-003 TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17
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 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090596-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL AB 2010-09-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090596-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL AB 2010-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090596-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL AB 2010-09-17 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198377 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 43353-317-09 Tacrolimus 9000 in 1 BOTTLE, PLASTIC CAPSULE 9000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-317 TACROLIMUS CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20171026_4caa20af-45a8-4365-9f06-1568afae61b1.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tacrolimus TACROLIMUS Safecor Health LLC 393cd10e-133c-4d6b-b024-270eb82edbb3 2026-04-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090596 application number: ANDA090596 Tacrolimus TACROLIMUS Golden State Medical Supply, Inc. 34ec4989-6933-4237-ae1e-50a0cb90a2fe 2025-12-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090596 application number: ANDA090596 Tacrolimus TACROLIMUS Mylan Pharmaceuticals Inc. 45af3eda-caaa-4478-9372-95aa65adc9b3 2025-08-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090596 application number: ANDA090596 Tacrolimus TACROLIMUS MylanInstitutional Inc. 5f742224-618e-4f4c-bdec-7693be99c697 2025-07-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090596 application number: ANDA090596 Tacrolimus TACROLIMUS Aphena Pharma Solutions - Tennessee, LLC 4caa20af-45a8-4365-9f06-1568afae61b1 2017-05-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 090596 application number: ANDA090596 ndc (product): 43353-317
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43353-317-09 43353031709 9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-317-09) 9000 capsule 2017-05-03 0000-00-00 No No Current