Home NDC 42291-478 Etonogestrel and Ethinyl Estradiol Vaginal
Product NDC 42291-478
11-digit product format 422910478
Labeler code 42291
Product ID 42291-478_1cbd9870-3ef2-b5c9-e063-6394a90a2dbd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etonogestrel and Ethinyl Estradiol Vaginal
Dosage form RING
Route VAGINAL
Labeler AvKARE
Application ANDA211157
Marketing category ANDA
Marketing start 2023-09-21
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211157-001 ENILLORING ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211157-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211157-001 ENILLORING 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2023-06-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Etonogestrel and Ethinyl Estradiol Vaginal
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHINYL ESTRADIOL .015 mg/d ETONOGESTREL .12 mg/d
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 423D2T571U Internal UNII lookup 304GTH6RNH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1367436 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-478-03 Etonogestrel and Ethinyl Estradiol Vaginal 3 in 1 CARTON RING 3 4 42291-478-11 Etonogestrel and Ethinyl Estradiol Vaginal 21 d in 1 POUCH RING 21 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-478 ETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RING [AVKARE] 4 Current NDC, 2 package rows 20240710_05e172aa-e18a-427b-e063-6294a90ae22f.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42291-478-03 42291047803 3 POUCH in 1 CARTON (42291-478-03) / 21 d in 1 POUCH (42291-478-11) 3 pouch 2023-09-21 No No Current 42291-478-11 42291047811 21 d in 1 POUCH 21 d Historical