Etonogestrel and Ethinyl Estradiol Vaginal Ring

Product NDC
16714-029
11-digit product format
167140029
Labeler code
16714
Product ID
16714-029_d1abad0a-e21f-d995-a4c6-b2e366309863
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etonogestrel and Ethinyl Estradiol Vaginal Ring
Dosage form
RING
Route
VAGINAL
Labeler
Northstar Rx LLC
Application
ANDA211157
Marketing category
ANDA
Marketing start
2023-11-01
Substance
ETHINYL ESTRADIOL; ETONOGESTREL
Active strength
.015; .12 mg/d; mg/d
Pharmacologic classes
Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Etonogestrel and Ethinyl Estradiol Vaginal Ring
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETHINYL ESTRADIOL.015 mg/d
ETONOGESTREL.12 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
Unii423D2T571U, 304GTH6RNH
Rxcui1367436

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
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8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
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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
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
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
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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
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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
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b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
03fd8ce8-4166-aad3-3bb9-c26530b16888Product name120140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-029-01Etonogestrel and Ethinyl Estradiol Vaginal Ring21 d in 1 POUCHRING212
16714-029-03Etonogestrel and Ethinyl Estradiol Vaginal Ring3 in 1 CARTONRING32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-029ETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RING RING [NORTHSTAR RX LLC]2Current NDC, 2 package rows20240713_1488f5ae-3b34-fcd7-6049-215929b1d324.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367436etonogestrel 0.12 MG / ethinyl estradiol 0.015 MG per 24HR 3 Week Vaginal SystemPSN1488f5ae-3b34-fcd7-6049-215929b1d3242
136743621 DAY ethinyl estradiol 0.000625 MG/HR / etonogestrel 0.005 MG/HR Vaginal SystemSCD1488f5ae-3b34-fcd7-6049-215929b1d3242
1367436ethinyl estradiol 0.015 MG / etonogestrel 0.12 MG per 24HR 3 Week Vaginal SystemSY1488f5ae-3b34-fcd7-6049-215929b1d3242
1367436ethinyl estradiol 15 MCG / etonogestrel 120 MCG per 24HR 3 Week Vaginal SystemSY1488f5ae-3b34-fcd7-6049-215929b1d3242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16714-029-011671400290121 d in 1 POUCH21 dHistorical
16714-029-03167140029033 POUCH in 1 CARTON (16714-029-03) / 21 d in 1 POUCH (16714-029-01) 3 pouch2023-11-01NoNoCurrent