Home NDC 50222-211-60 Protopic
Product NDC 50222-211
Requested package NDC 50222-211-60
11-digit product format 502220211
Labeler code 50222
Product ID 50222-211_f859e9b6-d4c5-472e-b165-24a05897dd79
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form OINTMENT
Route TOPICAL
Labeler LEO Pharma Inc
Application NDA050777
Marketing category NDA
Marketing start 2000-12-08
Marketing end 2024-12-31
Substance TACROLIMUS
Active strength 1 mg/g
Pharmacologic classes Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050777-001 PROTOPIC TACROLIMUS 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 N050777-002 PROTOPIC TACROLIMUS 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 84 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 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050777-001 PROTOPIC 0.03% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050777-002 PROTOPIC 0.1% OINTMENT / TOPICAL AB RLD, RS 2000-12-08 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 Padagis Israel Pharmaceuticals Ltd 6b601eaf-4f3a-4a8b-8cd8-1000defa9822 2021-11-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 050777 application number: NDA050777
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50222-211-60 50222021160 1 TUBE in 1 CARTON (50222-211-60) > 60 g in 1 TUBE 1 tube 2016-08-19 2024-08-31 No No Current