FDA.reportPublic FDA data

Myfembree

Product NDC
72974-415
11-digit product format
729740415
Labeler code
72974
Product ID
72974-415_d0b51ef8-0118-4b78-a83f-73338d6dab9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
relugolix, estradiol hemihydrate, and norethindrone acetate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sumitomo Pharma America, Inc
Application
NDA214846
Marketing category
NDA
Marketing start
2021-05-26
Substance
RELUGOLIX; ESTRADIOL HEMIHYDRATE; NORETHINDRONE ACETATE
Active strength
40; 1; .5 mg/1; mg/1; mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Progesterone Congeners [CS], Progestin [EPC]
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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214846-001MYFEMBREEESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214846-00180582802026-01-28Drug substance, Drug product2021-06-21
N214846-00173009352029-01-28Drug substance2021-06-21
N214846-001117951782033-09-27Drug substance, Drug product2023-10-25
N214846-001123257142033-09-27Drug substance, Drug product2025-06-11
N214846-001110335512037-09-29U-31292021-06-21
N214846-001119576842037-09-29U-31292024-04-17
N214846-001117938122038-05-03U-23602023-10-25
N214846-001125514472042-11-05Drug product2026-02-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N214846-001M-2892026-01-27

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-2684e616aacf4f…
2026-08-18 06:07:402026-07N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-264b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214846-001MYFEMBREE1MG;0.5MG;40MGTABLET / ORALRLD, RS2021-05-26a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N214846-00180582802026-01-28Drug substance, Drug product2021-06-2184e616aacf4f…
2026-09-14 22:38:342026-08N214846-00173009352029-01-28Drug substance2021-06-2184e616aacf4f…
2026-09-14 22:38:342026-08N214846-001117951782033-09-27Drug substance, Drug product2023-10-2584e616aacf4f…
2026-09-14 22:38:342026-08N214846-001123257142033-09-27Drug substance, Drug product2025-06-1184e616aacf4f…
2026-09-14 22:38:342026-08N214846-001110335512037-09-29U-31292021-06-2184e616aacf4f…
2026-09-14 22:38:342026-08N214846-001119576842037-09-29U-31292024-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N214846-001117938122038-05-03U-23602023-10-2584e616aacf4f…
2026-09-14 22:38:342026-08N214846-001125514472042-11-05Drug product2026-02-2384e616aacf4f…
2026-08-18 06:07:402026-07N214846-00180582802026-01-28Drug substance, Drug product2021-06-21caaa826d4ba7…
2026-08-18 06:07:402026-07N214846-00173009352029-01-28Drug substance2021-06-21caaa826d4ba7…
2026-08-18 06:07:402026-07N214846-001117951782033-09-27Drug substance, Drug product2023-10-25caaa826d4ba7…
2026-08-18 06:07:402026-07N214846-001123257142033-09-27Drug substance, Drug product2025-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N214846-001110335512037-09-29U-31292021-06-21caaa826d4ba7…
2026-08-18 06:07:402026-07N214846-001119576842037-09-29U-31292024-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07N214846-001117938122038-05-03U-23602023-10-25caaa826d4ba7…
2026-08-18 06:07:402026-07N214846-001125514472042-11-05Drug product2026-02-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214846-00180582802026-01-28Drug substance, Drug product2021-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214846-00173009352029-01-28Drug substance2021-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214846-001117951782033-09-27Drug substance, Drug product2023-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214846-001123257142033-09-27Drug substance, Drug product2025-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214846-001110335512037-09-29U-31292021-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214846-001119576842037-09-29U-31292024-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214846-001117938122038-05-03U-23602023-10-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214846-00180582802026-01-28Drug substance, Drug product2021-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214846-00173009352029-01-28Drug substance2021-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214846-001117951782033-09-27Drug substance, Drug product2023-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214846-001123257142033-09-27Drug substance, Drug product2025-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214846-001110335512037-09-29U-31292021-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214846-001119576842037-09-29U-31292024-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214846-001117938122038-05-03U-23602023-10-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N214846-00173009352026-01-28Drug substance2021-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214846-00180582802026-01-28Drug substance, Drug product2021-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214846-001117951782033-09-27Drug substance, Drug product2023-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214846-001123257142033-09-27Drug substance, Drug product2025-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214846-001110335512037-09-29U-31292021-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214846-001119576842037-09-29U-31292024-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214846-001117938122038-05-03U-23602023-10-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214846-00173009352026-01-28Drug substance2021-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214846-00180582802026-01-28Drug substance, Drug product2021-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214846-001117951782033-09-27Drug substance, Drug product2023-10-25fd3edfee7708…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 107 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N214846-001M-2892026-01-2784e616aacf4f…
2026-08-18 06:07:402026-07N214846-001M-2892026-01-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214846-001M-2892026-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214846-001I-8982025-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214846-001NCE2025-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214846-001M-2892026-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N214846-001I-8982025-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214846-001NCE2025-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214846-001M-2892026-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214846-001I-8982025-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214846-001NCE2025-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214846-001M-2892026-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214846-001I-8982025-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214846-001NCE2025-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214846-001M-2892026-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214846-001NP2024-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214846-001I-8982025-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214846-001NCE2025-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214846-001M-2892026-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214846-001NP2024-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214846-001I-8982025-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214846-001NCE2025-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214846-001M-2892026-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214846-001NP2024-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214846-001I-8982025-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214846-001NCE2025-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214846-001M-2892026-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214846-001NP2024-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214846-001I-8982025-08-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214846-001NCE2025-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214846-001M-2892026-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214846-001NP2024-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N214846-001I-8982025-08-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N214846-001NCE2025-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N214846-001M-2892026-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214846-001NP2024-05-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214846-001I-8982025-08-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214846-001NCE2025-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214846-001M-2892026-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214846-001NP2024-05-26301d65b070ca…

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
Myfembree
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RELUGOLIX40 mg/1
ESTRADIOL HEMIHYDRATE1 mg/1
NORETHINDRONE ACETATE.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P76B05O5V6Internal UNII lookup
CXY7B3Q98ZInternal UNII lookup
9S44LIC7OJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2556799Internal RxNorm lookup
2556800Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc3feb73-cc84-43a8-aa32-b262460495e8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
6c4d424e-6243-4523-bf62-cb9f42ba3b2bProduct name120210609
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
f6ac5560-6d3b-d281-41d2-adc50d283c20Product name320170228
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72974-415-01Myfembree28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2818
72974-415-99Myfembree7 in 1 BOTTLE, PLASTICTABLET, FILM COATED718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72974-415-01EA - Each72974-415d20d69b4-870e-4617-8fa9-fbbbbb454e9612021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72974-415MYFEMBREE (RELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATE) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC]17Current NDC, Legacy NDC, 2 package rows20240724_fc3feb73-cc84-43a8-aa32-b262460495e8.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyfembreeRELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATESumitomo Pharma America, Incfc3feb73-cc84-43a8-aa32-b262460495e82025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 214846
application number: NDA214846
ndc (product): 72974-415

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2556799estradiol 1 MG / norethindrone acetate 0.5 MG / relugolix 40 MG Oral TabletPSNfc3feb73-cc84-43a8-aa32-b262460495e818
2556800Myfembree (relugolix 40 MG / estradiol 1 MG / norethindrone acetate 0.5 MG) Oral TabletPSNfc3feb73-cc84-43a8-aa32-b262460495e818
2556800estradiol 1 MG / norethindrone acetate 0.5 MG / relugolix 40 MG Oral Tablet [Myfembree]SBDfc3feb73-cc84-43a8-aa32-b262460495e818
2556799estradiol 1 MG / norethindrone acetate 0.5 MG / relugolix 40 MG Oral TabletSCDfc3feb73-cc84-43a8-aa32-b262460495e818
2556800Myfembree (relugolix 40 MG / estradiol 1 MG / norethindrone acetate 0.5 MG) Oral TabletSYfc3feb73-cc84-43a8-aa32-b262460495e818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72974-415-017297404150128 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01) 2021-05-260000-00-00NoNoCurrent
72974-415-99729740415997 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99) 2021-07-070000-00-00NoNoCurrent