Home NDC 82576-060 REZDIFFRA
Product NDC 82576-060
11-digit product format 825760060
Labeler code 82576
Product ID 82576-060_1fec1a4b-28d9-41c3-ae32-59b53cd41f07
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Resmetirom
Dosage form TABLET, COATED
Route ORAL
Labeler Madrigal Pharmaceuticals, Inc.
Application NDA217785
Marketing category NDA
Marketing start 2024-03-14
Substance RESMETIROM
Active strength 60 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Thyroid Hormone Receptor beta Agonist [EPC], Thyroid Hormone Receptor beta Agonists [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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217785-001 REZDIFFRA RESMETIROM 60MG TABLET / ORAL RLD 2024-03-14 N217785-002 REZDIFFRA RESMETIROM 80MG TABLET / ORAL RLD 2024-03-14 N217785-003 REZDIFFRA RESMETIROM 100MG TABLET / ORAL RLD, RS 2024-03-14
Orange Book patents# Current patent rows page 1 of 1 · 22 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217785-001 7452882 2027-09-12 Drug substance, Drug product 2024-04-03 N217785-001 10376517 2033-09-17 U-3861 2024-04-03 N217785-001 11564926 2033-09-17 U-3861 Drug substance, Drug product 2024-04-03 N217785-001 11986481 2033-09-17 U-3861 2024-06-05 N217785-001 9266861 2033-09-17 Drug substance, Drug product 2024-04-03 N217785-001 12661359 2042-01-28 U-4568 2026-07-13 N217785-001 12667575 2045-02-04 U-4567 2026-07-13 N217785-002 7452882 2027-09-12 Drug substance, Drug product 2024-04-03 N217785-002 10376517 2033-09-17 U-3861 2024-04-03 N217785-002 11564926 2033-09-17 U-3861 Drug substance, Drug product 2024-04-03 N217785-002 11986481 2033-09-17 U-3861 2024-06-05 N217785-002 9266861 2033-09-17 Drug substance, Drug product 2024-04-03 N217785-002 12661359 2042-01-28 U-4568 2026-07-13 N217785-002 12377104 2045-02-04 U-3861 2025-08-15 N217785-002 12667575 2045-02-04 U-4567 2026-07-13 N217785-003 7452882 2027-09-12 Drug substance, Drug product 2024-04-03 N217785-003 10376517 2033-09-17 U-3861 2024-04-03 N217785-003 11564926 2033-09-17 U-3861 Drug substance, Drug product 2024-04-03 N217785-003 11986481 2033-09-17 U-3861 2024-06-05 N217785-003 9266861 2033-09-17 Drug substance, Drug product 2024-04-03 N217785-003 12661359 2042-01-28 U-4568 2026-07-13 N217785-003 12377104 2045-02-04 U-3861 2025-08-15
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217785-001 NCE 2029-03-14 N217785-002 NCE 2029-03-14 N217785-003 NCE 2029-03-14
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 2 · 54 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 2026-10-15 13:18:30 2026-09 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217785-002 REZDIFFRA 80MG TABLET / ORAL RLD 2024-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217785-003 REZDIFFRA 100MG TABLET / ORAL RLD, RS 2024-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217785-001 REZDIFFRA 60MG TABLET / ORAL RLD 2024-03-14 79d66fd596c7…
Observed Orange Book patent history# Patent history page 1 of 8 · 297 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N217785-001 7452882 2027-09-12 Drug substance, Drug product 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-001 10376517 2033-09-17 U-3861 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-001 11564926 2033-09-17 U-3861 Drug substance, Drug product 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-001 11986481 2033-09-17 U-3861 2024-06-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-001 9266861 2033-09-17 Drug substance, Drug product 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-001 12661359 2042-01-28 U-4568 2026-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-001 12667575 2045-02-04 U-4567 2026-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-002 7452882 2027-09-12 Drug substance, Drug product 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-002 10376517 2033-09-17 U-3861 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-002 11564926 2033-09-17 U-3861 Drug substance, Drug product 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-002 11986481 2033-09-17 U-3861 2024-06-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-002 9266861 2033-09-17 Drug substance, Drug product 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-002 12661359 2042-01-28 U-4568 2026-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-002 12377104 2045-02-04 U-3861 2025-08-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-002 12667575 2045-02-04 U-4567 2026-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-003 7452882 2027-09-12 Drug substance, Drug product 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-003 10376517 2033-09-17 U-3861 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-003 11564926 2033-09-17 U-3861 Drug substance, Drug product 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-003 11986481 2033-09-17 U-3861 2024-06-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-003 9266861 2033-09-17 Drug substance, Drug product 2024-04-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-003 12661359 2042-01-28 U-4568 2026-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N217785-003 12377104 2045-02-04 U-3861 2025-08-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 N217785-001 7452882 2027-09-12 Drug substance, Drug product 2024-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-001 10376517 2033-09-17 U-3861 2024-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-001 11564926 2033-09-17 U-3861 Drug substance, Drug product 2024-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-001 11986481 2033-09-17 U-3861 2024-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-001 9266861 2033-09-17 Drug substance, Drug product 2024-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-001 12661359 2042-01-28 U-4568 2026-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-001 12667575 2045-02-04 U-4567 2026-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-002 7452882 2027-09-12 Drug substance, Drug product 2024-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-002 10376517 2033-09-17 U-3861 2024-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-002 11564926 2033-09-17 U-3861 Drug substance, Drug product 2024-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-002 11986481 2033-09-17 U-3861 2024-06-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-002 9266861 2033-09-17 Drug substance, Drug product 2024-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-002 12661359 2042-01-28 U-4568 2026-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-002 12377104 2045-02-04 U-3861 2025-08-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-002 12667575 2045-02-04 U-4567 2026-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-003 7452882 2027-09-12 Drug substance, Drug product 2024-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-003 10376517 2033-09-17 U-3861 2024-04-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217785-003 11564926 2033-09-17 U-3861 Drug substance, Drug product 2024-04-03 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 54 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base REZDIFFRA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RESMETIROM 60 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RE0V0T1ES0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2677899 Internal RxNorm lookup 2677905 Internal RxNorm lookup 2677907 Internal RxNorm lookup 2677909 Internal RxNorm lookup 2677911 Internal RxNorm lookup 2677913 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82576-060-30 REZDIFFRA 30 in 1 BOTTLE TABLET, COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82576-060 REZDIFFRA (RESMETIROM) TABLET, COATED REZDIFFRA (RESMETIROM) TABLET, COATED REZDIFFRA (RESMETIROM) TABLET, COATED [MADRIGAL PHARMACEUTICALS, INC.] 2 Current NDC, 1 package rows 20250228_e67ea09f-a840-439c-86c8-f98585f978b2.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 Marketing start Sample Exclude flag Status 82576-060-30 82576006030 30 TABLET, COATED in 1 BOTTLE (82576-060-30) 2024-03-14 No No Current