Home NDC 0168-0417-99 Tacrolimus
Product NDC 0168-0417
Requested package NDC 0168-0417-99
11-digit product format 001680417
Labeler code 0168
Product ID 0168-0417_a63cc4f4-5aba-4e02-915a-5535f2b625aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tacrolimus
Dosage form OINTMENT
Route TOPICAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application ANDA200744
Marketing category ANDA
Marketing start 2014-09-09
Substance TACROLIMUS
Active strength .3 mg/g
Pharmacologic classes Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200744-001 TACROLIMUS TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 A200744-002 TACROLIMUS TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tacrolimus
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TACROLIMUS .3 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0417 TACROLIMUS OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 12 Current NDC, Legacy NDC, 6 package rows 20231102_1bf44a84-14fd-4f80-ad8a-99b1431d631f.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 0168-0417-99 00168041799 1 TUBE in 1 CARTON (0168-0417-99) / 100 g in 1 TUBE 1 tube 2014-09-09 0000-00-00 No No Current