Home NDC 68308-703-60 Tacrolimus
Product NDC 68308-703
Requested package NDC 68308-703-60
11-digit product format 683080703
Labeler code 68308
Product ID 68308-703_8f81ec98-b84c-4446-9ccb-6c2280a22694
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tacrolimus
Dosage form OINTMENT
Route TOPICAL
Labeler Mayne Pharma Inc.
Application ANDA200744
Marketing category ANDA
Marketing start 2014-09-09
Marketing end 0000-00-00
Substance TACROLIMUS
Active strength 1 mg/g
Pharmacologic classes Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 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 · 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 A200744-001 TACROLIMUS 0.03% OINTMENT / TOPICAL AB 2014-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200744-002 TACROLIMUS 0.1% OINTMENT / TOPICAL AB 2014-09-09 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68308-703 TACROLIMUS OINTMENT [MAYNE PHARMA INC.] 4 Legacy NDC 20240417_de81b7df-a4d6-431f-8ec4-06755a417da8.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 E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC 1bf44a84-14fd-4f80-ad8a-99b1431d631f 2026-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200744 application number: ANDA200744
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68308-703-60 68308070360 1 TUBE in 1 CARTON (68308-703-60) > 60 g in 1 TUBE 1 tube 2021-12-08 0000-00-00 No No Current