FDA.reportPublic FDA data

FEMLYV

Product NDC
72495-601
Requested package NDC
72495-601-28
11-digit product format
724950601
Labeler code
72495
Product ID
72495-601_5bfa2209-e9bb-4d9b-97cb-2f8cd0058178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone Acetate/Ethinyl Estradiol
Dosage form
KIT
Labeler
Millicent US, Inc.
Application
NDA218718
Marketing category
NDA
Marketing start
2024-11-01
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
N218718-001FEMLYVETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218718-001121788242041-06-24Drug product2025-01-10

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218718-001NP2027-07-22

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 22:38:342026-08N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-2284e616aacf4f…
2026-08-18 06:07:402026-07N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-2279d66fd596c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218718-001FEMLYV0.02MG;1MGTABLET, ORALLY DISINTEGRATING / ORALRLD, RS2024-07-22a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N218718-001121788242041-06-24Drug product2025-01-1084e616aacf4f…
2026-08-18 06:07:402026-07N218718-001121788242041-06-24Drug product2025-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218718-001121788242041-06-24Drug product2025-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218718-001121788242041-06-24Drug product2025-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N218718-001121788242041-06-24Drug product2025-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218718-001121788242041-06-24Drug product2025-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218718-001121788242041-06-24Drug product2025-01-10b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218718-001121788242041-06-24Drug product2025-01-10a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N218718-001NP2027-07-2284e616aacf4f…
2026-08-18 06:07:402026-07N218718-001NP2027-07-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218718-001NP2027-07-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218718-001NP2027-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N218718-001NP2027-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218718-001NP2027-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218718-001NP2027-07-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218718-001NP2027-07-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218718-001NP2027-07-222680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218718-001NP2027-07-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218718-001NP2027-07-22d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218718-001NP2027-07-22a50c72e98297…

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
FEMLYV
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2696883Internal RxNorm lookup
2696886Internal RxNorm lookup
2696887Internal RxNorm lookup
2696888Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3c99fc1-9b05-4f0a-ad00-5e3e206302c9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8Product name420170608
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
f6ac5560-6d3b-d281-41d2-adc50d283c20Product name320170228
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
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
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72495-601-28FEMLYV1 in 1 CARTONKIT13
72495-601-28FEMLYV1 in 1 POUCHKIT13
72495-601-84FEMLYV1 in 1 POUCHKIT13
72495-601-84FEMLYV3 in 1 CARTONKIT33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72495-601-28EA - Each72495-601ffaee21b-5a8e-4841-9b15-b1f30254f88a12024-10-04
72495-601-84EA - Each72495-601aa0e98f1-bdef-45ad-8aa3-a0e55cbafa0a12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72495-601FEMLYV (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) KIT [MILLICENT US, INC.]2Current NDC, 4 package rows20241102_a3c99fc1-9b05-4f0a-ad00-5e3e206302c9.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
FEMLYVNORETHINDRONE ACETATE/ETHINYL ESTRADIOLMillicent US, Inc.a3c99fc1-9b05-4f0a-ad00-5e3e206302c92025-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 218718
application number: NDA218718
ndc (package): 72495-601-28
ndc (product): 72495-601
ndc11 (package): 72495060128

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2696888{24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet) / 4 (inert ingredients 1 MG Disintegrating Oral Tablet) } Pack [Femlyv 24 ODT 28 Day]BPCKa3c99fc1-9b05-4f0a-ad00-5e3e206302c93
2696887{24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet) / 4 (inert ingredients 1 MG Disintegrating Oral Tablet) } PackGPCKa3c99fc1-9b05-4f0a-ad00-5e3e206302c93
2696883ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral TabletPSNa3c99fc1-9b05-4f0a-ad00-5e3e206302c93
2696887ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet 28 Day PackPSNa3c99fc1-9b05-4f0a-ad00-5e3e206302c93
2696888FEMLYV 24 ODT 28 Day PackPSNa3c99fc1-9b05-4f0a-ad00-5e3e206302c93
2696886inert ingredients 1 MG Disintegrating Oral TabletPSNa3c99fc1-9b05-4f0a-ad00-5e3e206302c93
2696883ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral TabletSCDa3c99fc1-9b05-4f0a-ad00-5e3e206302c93
2696886inert ingredients 1 MG Disintegrating Oral TabletSCDa3c99fc1-9b05-4f0a-ad00-5e3e206302c93
2696887ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Disintegrating Oral Tablet 28 Day PackSYa3c99fc1-9b05-4f0a-ad00-5e3e206302c93
2696883ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Disintegrating Oral TabletSYa3c99fc1-9b05-4f0a-ad00-5e3e206302c93
2696888Femlyv 24 ODT 28 Day PackSYa3c99fc1-9b05-4f0a-ad00-5e3e206302c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72495-601-28724950601281 POUCH in 1 CARTON (72495-601-28) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK1 pouch2024-11-01NoNoCurrent