Home NDC 14789-135 Tacrolimus
Product NDC 14789-135
11-digit product format 147890135
Labeler code 14789
Product ID 14789-135_44fc0987-ff9d-3099-e063-6394a90a7a55
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form INJECTION
Route INTRAVENOUS
Labeler Nexus Pharmaceuticals, LLC
Application ANDA217108
Marketing category ANDA
Marketing start 2025-12-01
Substance TACROLIMUS
Active strength 5 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217108-001 TACROLIMUS TACROLIMUS EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2025-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217108-001 AP
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.
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 A217108-001 TACROLIMUS EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2025-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217108-001 TACROLIMUS EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2025-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217108-001 TACROLIMUS EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2025-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217108-001 TACROLIMUS EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2025-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217108-001 TACROLIMUS EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2025-02-12 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217108-001 TACROLIMUS EQ 5MG BASE/ML INJECTABLE / INJECTION AP 2025-02-12 a50c72e98297…
Observed Orange Book normalized TE history# 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/mL
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 198379 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 14789-135-05 Tacrolimus 10 in 1 CARTON INJECTION 10 11 14789-135-07 Tacrolimus 1 mL in 1 VIAL INJECTION 1 11
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 14789-135-05 14789013505 10 VIAL in 1 CARTON (14789-135-05) / 1 mL in 1 VIAL (14789-135-07) 10 vial 2025-12-01 No No Current 14789-135-07 14789013507 1 mL in 1 VIAL 1 ml Historical