Home NDC 71335-2189 Tacrolimus
Product NDC 71335-2189
11-digit product format 713352189
Labeler code 71335
Product ID 71335-2189_bcd0e46a-cabb-4a0d-81c8-f41368a3bd74
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA091195
Marketing category ANDA
Marketing start 2011-09-30
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 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 A091195-001 TACROLIMUS TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 A091195-002 TACROLIMUS TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 A091195-003 TACROLIMUS TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31
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 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091195-002 TACROLIMUS EQ 1MG BASE CAPSULE / ORAL BX 2011-08-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091195-003 TACROLIMUS EQ 5MG BASE CAPSULE / ORAL BX 2011-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091195-001 TACROLIMUS EQ 0.5MG BASE CAPSULE / ORAL BX 2011-08-31 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 .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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 71335-2189-1 Tacrolimus 60 in 1 BOTTLE CAPSULE 60 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2189 TACROLIMUS CAPSULE [BRYANT RANCH PREPACK] 102 Current NDC, 1 package rows 20240420_a2e55495-10cc-4f6e-b866-1e7d6e45888b.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 · 3 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 71335-2189-1 71335218901 60 CAPSULE in 1 BOTTLE (71335-2189-1) 60 capsule 2022-11-03 No No Current