FDA.reportPublic FDA data

IMVEXXY

Product NDC
50261-104
11-digit product format
502610104
Labeler code
50261
Product ID
50261-104_3ef13c12-867e-6b00-e063-6394a90abaa3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
INSERT
Route
VAGINAL
Labeler
Mayne Pharma LLC
Application
NDA208564
Marketing category
NDA
Marketing start
2018-07-05
Substance
ESTRADIOL
Active strength
4 ug/1
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IMVEXXY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL4 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui884707, 2048916, 2048917, 2048918, 2054309, 2054310, 2054312, 2054313, 2054315, 2054316, 2054317, 2054318

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
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50261-104-02IMVEXXY1 in 1 CARTONINSERT113
50261-104-02IMVEXXY2 in 1 BLISTER PACKINSERT213
50261-104-08IMVEXXY1 in 1 CARTONINSERT113
50261-104-08IMVEXXY8 in 1 BLISTER PACKINSERT813
50261-104-18IMVEXXY1 in 1 CARTONINSERT113
50261-104-18IMVEXXY18 in 1 BLISTER PACKINSERT1813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50261-104-08EA - Each50261-104707d930a-fba9-46ea-9b0e-293dda36351112018-07-03
50261-104-18EA - Each50261-104b256e3a6-03da-41a6-b266-5e3b4d831cac12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50261-104IMVEXXY (ESTRADIOL) INSERT [MAYNE PHARMA LLC]12Current NDC, Legacy NDC, 6 package rows20250322_104be9f2-a8f6-430e-9e01-2ee7cc1861f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2054313{18 (estradiol 0.004 MG Vaginal Insert [Imvexxy]) } Pack [Imvexxy 4 MCG Starter Pack]BPCK104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054318{18 (estradiol 0.01 MG Vaginal Insert [Imvexxy]) } Pack [Imvexxy 10 MCG Starter Pack]BPCK104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054310{8 (estradiol 0.004 MG Vaginal Insert [Imvexxy]) } Pack [Imvexxy 4 MCG Maintenance Pack]BPCK104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054316{8 (estradiol 0.01 MG Vaginal Insert [Imvexxy]) } Pack [Imvexxy 10 MCG Maintenance Pack]BPCK104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054312{18 (estradiol 0.004 MG Vaginal Insert) } PackGPCK104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054317{18 (estradiol 0.01 MG Vaginal Insert) } PackGPCK104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054309{8 (estradiol 0.004 MG Vaginal Insert) } PackGPCK104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054315{8 (estradiol 0.01 MG Vaginal Insert) } PackGPCK104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054317estradiol 10 MCG (18) Vaginal Insert Starter PackPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054315estradiol 10 MCG 8 Vaginal Insert Maintenance PackPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
884707estradiol 10 MCG Vaginal InsertPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054312estradiol 4 MCG (18) Vaginal Insert Starter PackPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054309estradiol 4 MCG (8) Vaginal Insert Maintenance PackPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2048917estradiol 4 MCG Vaginal InsertPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054316Imvexxy 10 MCG Maintenance PackPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054318Imvexxy 10 MCG Starter PackPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2048916Imvexxy 10 MCG Vaginal InsertPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054310Imvexxy 4 MCG Maintenance PackPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054313Imvexxy 4 MCG Starter PackPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2048918Imvexxy 4 MCG Vaginal InsertPSN104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2048918estradiol 0.004 MG Vaginal Insert [Imvexxy]SBD104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2048916estradiol 0.01 MG Vaginal Insert [Imvexxy]SBD104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2048917estradiol 0.004 MG Vaginal InsertSCD104be9f2-a8f6-430e-9e01-2ee7cc1861f113
884707estradiol 0.01 MG Vaginal InsertSCD104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054317estradiol 10 MCG (18) Vaginal Insert Starter PackSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054315estradiol 10 MCG 8 Vaginal Insert Maintenance PackSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
884707estradiol 10 MCG Vaginal InsertSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054312estradiol 4 MCG (18) Vaginal Insert Starter PackSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054309estradiol 4 MCG (8) Vaginal Insert Maintenance PackSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2048917estradiol 4 MCG Vaginal InsertSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2048918Imvexxy 0.004 MG Vaginal InsertSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2048916Imvexxy 0.01 MG Vaginal InsertSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054316Imvexxy 10 MCG Maintenance PackSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054318Imvexxy 10 MCG Starter PackSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2048916Imvexxy 10 MCG Vaginal InsertSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054310Imvexxy 4 MCG Maintenance PackSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2054313Imvexxy 4 MCG Starter PackSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113
2048918Imvexxy 4 MCG Vaginal InsertSY104be9f2-a8f6-430e-9e01-2ee7cc1861f113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50261-104-02502610104021 BLISTER PACK in 1 CARTON (50261-104-02) > 2 INSERT in 1 BLISTER PACK1 blister pack2018-08-100000-00-00YesNoCurrent
50261-104-08502610104081 BLISTER PACK in 1 CARTON (50261-104-08) > 8 INSERT in 1 BLISTER PACK1 blister pack2018-08-100000-00-00NoNoCurrent
50261-104-18502610104181 BLISTER PACK in 1 CARTON (50261-104-18) > 18 INSERT in 1 BLISTER PACK1 blister pack2018-08-100000-00-00NoNoCurrent