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 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 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 2026-08-01 22:54:32 2026-06 A210830-001 ELURYNG 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2019-12-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A210830-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Additional Listing Data#
Finished product Yes
Brand name base EluRyng
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETONOGESTREL .015 mg/d ETHINYL ESTRADIOL .12 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
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