Home NDC 45802-700 Tacrolimus
Product NDC 45802-700
11-digit product format 458020700
Labeler code 45802
Product ID 45802-700_ca08f41f-bc87-45bb-91b8-1d89adfba78f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tacrolimus
Dosage form OINTMENT
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application NDA050777
Marketing category NDA
Marketing start 2014-11-20
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 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.
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313189 Internal RxNorm lookup 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 Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-700 TACROLIMUS OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD] 9 Current NDC, Legacy NDC, 6 package rows 20230505_6b601eaf-4f3a-4a8b-8cd8-1000defa9822.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.
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 45802-700-00 45802070000 1 TUBE in 1 CARTON (45802-700-00) / 30 g in 1 TUBE 1 tube 2014-11-20 0000-00-00 No No Current 45802-700-01 45802070001 1 TUBE in 1 CARTON (45802-700-01) / 60 g in 1 TUBE 1 tube 2014-11-20 0000-00-00 No No Current 45802-700-02 45802070002 1 TUBE in 1 CARTON (45802-700-02) / 100 g in 1 TUBE 1 tube 2014-11-20 0000-00-00 No No Current