Home NDC 21922-011 Tacrolimus
Product NDC 21922-011
11-digit product format 219220011
Labeler code 21922
Product ID 21922-011_9197a805-bb44-44b8-9ae7-d39a01acb1a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus Ointment 0.1%
Dosage form OINTMENT
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA212387
Marketing category ANDA
Marketing start 2023-10-13
Substance TACROLIMUS
Active strength 1 mg/g
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 A212387-001 TACROLIMUS TACROLIMUS 0.1% OINTMENT / TOPICAL BX 2023-10-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212387-001 BX
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 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL BX 2023-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL BX 2023-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL BX 2023-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2023-10-10 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212387-001 TACROLIMUS 0.1% OINTMENT / TOPICAL BX 2023-10-10 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 1 mg/g
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 314266 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-011 TACROLIMUS (TACROLIMUS OINTMENT 0.1%) OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED] 3 Current NDC, 6 package rows 20231016_43b38551-6c5e-48a4-a453-9286f1c16b34.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tacrolimus TACROLIMUS OINTMENT 0.1% Encube Ethicals, Inc. 43b38551-6c5e-48a4-a453-9286f1c16b34 2025-10-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212387 application number: ANDA212387 ndc (product): 21922-011
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 21922-011-05 21922001105 1 TUBE in 1 CARTON (21922-011-05) / 30 g in 1 TUBE 1 tube 2023-10-13 No No Current 21922-011-07 21922001107 1 TUBE in 1 CARTON (21922-011-07) / 60 g in 1 TUBE 1 tube 2023-10-13 No No Current 21922-011-09 21922001109 1 TUBE in 1 CARTON (21922-011-09) / 100 g in 1 TUBE 1 tube 2023-10-13 No No Current