REZDIFFRA

Product NDC: 82576-100
Requested package NDC: 82576-100-90
11-digit product format: 825760100
Labeler code: 82576
Product ID: 82576-100_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: 100 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	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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N217785-001	NCE	2029-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-002	NCE	2029-03-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217785-003	NCE	2029-03-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217785-001	NCE	2029-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-002	NCE	2029-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217785-003	NCE	2029-03-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217785-001	NCE	2029-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217785-002	NCE	2029-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217785-003	NCE	2029-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217785-001	NCE	2029-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217785-002	NCE	2029-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217785-003	NCE	2029-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217785-001	NCE	2029-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217785-002	NCE	2029-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217785-003	NCE	2029-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217785-001	NCE	2029-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217785-002	NCE	2029-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217785-003	NCE	2029-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217785-001	NCE	2029-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217785-002	NCE	2029-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217785-003	NCE	2029-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217785-001	NCE	2029-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217785-002	NCE	2029-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217785-003	NCE	2029-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217785-001	NCE	2029-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217785-002	NCE	2029-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217785-003	NCE	2029-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217785-001	NCE	2029-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217785-002	NCE	2029-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217785-003	NCE	2029-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217785-001	NCE	2029-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217785-002	NCE	2029-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217785-003	NCE	2029-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217785-001	NCE	2029-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217785-002	NCE	2029-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217785-003	NCE	2029-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217785-001	NCE	2029-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217785-002	NCE	2029-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217785-003	NCE	2029-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217785-001	NCE	2029-03-14	`79d66fd596c7…`

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	100 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e67ea09f-a840-439c-86c8-f98585f978b2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
84baaf7d-76f2-404f-a740-6547ea56384f	Product name	1	20250124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82576-100-30	REZDIFFRA	30 in 1 BOTTLE	TABLET, COATED	30		3
82576-100-90	REZDIFFRA	90 in 1 BOTTLE	TABLET, COATED	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82576-100-30	EA - Each	82576-100	35758c96-d222-4b1a-a5e7-c0b48b85e907	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82576-100	REZDIFFRA (RESMETIROM) TABLET, COATED REZDIFFRA (RESMETIROM) TABLET, COATED REZDIFFRA (RESMETIROM) TABLET, COATED [MADRIGAL PHARMACEUTICALS, INC.]	2	Current NDC, 2 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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REZDIFFRA	RESMETIROM	Madrigal Pharmaceuticals, Inc.	e67ea09f-a840-439c-86c8-f98585f978b2	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217785 application number: NDA217785 ndc (package): 82576-100-90 ndc (product): 82576-100 ndc11 (package): 82576010090

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RE0V0T1ES0	RESMETIROM	920509-32-6	RESMETIROM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2677899	resmetirom 100 MG Oral Tablet	PSN	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677907	resmetirom 60 MG Oral Tablet	PSN	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677911	resmetirom 80 MG Oral Tablet	PSN	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677905	Rezdiffra 100 MG Oral Tablet	PSN	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677909	Rezdiffra 60 MG Oral Tablet	PSN	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677913	Rezdiffra 80 MG Oral Tablet	PSN	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677905	resmetirom 100 MG Oral Tablet [Rezdiffra]	SBD	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677909	resmetirom 60 MG Oral Tablet [Rezdiffra]	SBD	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677913	resmetirom 80 MG Oral Tablet [Rezdiffra]	SBD	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677899	resmetirom 100 MG Oral Tablet	SCD	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677907	resmetirom 60 MG Oral Tablet	SCD	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677911	resmetirom 80 MG Oral Tablet	SCD	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677899	resmetirom 100 MG Oral Tablet	SY	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677907	resmetirom 60 MG Oral Tablet	SY	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677911	resmetirom 80 MG Oral Tablet	SY	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677905	Rezdiffra 100 MG Oral Tablet	SY	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677909	Rezdiffra 60 MG Oral Tablet	SY	e67ea09f-a840-439c-86c8-f98585f978b2	3
2677913	Rezdiffra 80 MG Oral Tablet	SY	e67ea09f-a840-439c-86c8-f98585f978b2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82576-100-90	82576010090	90 TABLET, COATED in 1 BOTTLE (82576-100-90)	2024-03-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
REZDIFFRA	Madrigal Pharmaceuticals, Inc. \| Corden Pharma GmbH	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	4