Home NDC 65162-469 EluRyng
Product NDC 65162-469
11-digit product format 651620469
Labeler code 65162
Product ID 65162-469_f4ebff86-0b26-41a2-9b3f-6bb4dabbe385
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etonogestrel and Ethinyl Estradiol
Dosage form RING
Route VAGINAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA210830
Marketing category ANDA
Marketing start 2019-12-16
Substance ETONOGESTREL; ETHINYL ESTRADIOL
Active strength .12; .015 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 43 .
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 A210830-001 ELURYNG ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210830-001 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 2026-09-14 22:38:34 2026-08 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 a50c72e98297…
Observed Orange Book normalized TE history# 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 EluRyng
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETONOGESTREL .12 mg/d ETHINYL ESTRADIOL .015 mg/d
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 304GTH6RNH Internal UNII lookup 423D2T571U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1367436 Internal RxNorm lookup 2266506 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 65162-469-32 EluRyng 21 d in 1 POUCH RING 21 21 65162-469-35 EluRyng 3 in 1 CARTON RING 3 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-469 ELURYNG (ETONOGESTREL AND ETHINYL ESTRADIOL) RING [AMNEAL PHARMACEUTICALS LLC] 21 Current NDC, Legacy NDC, 2 package rows 20250130_c6c8512d-b258-4be5-8c2f-0f1893f198b9.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EluRyng ETONOGESTREL AND ETHINYL ESTRADIOL Amneal Pharmaceuticals LLC c6c8512d-b258-4be5-8c2f-0f1893f198b9 2025-01-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210830 application number: ANDA210830 ndc (product): 65162-469
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65162-469-32 65162046932 21 d in 1 POUCH 21 d Historical 65162-469-35 65162046935 3 POUCH in 1 CARTON (65162-469-35) / 21 d in 1 POUCH (65162-469-32) 3 pouch 2019-12-16 0000-00-00 No No Current