Home NDC 0093-7679 Etonogestrel and Ethinyl Estradiol
Product NDC 0093-7679
11-digit product format 000937679
Labeler code 0093
Product ID 0093-7679_d0827dbf-9df5-4438-a0c2-92d7d593e71c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etonogestrel and Ethinyl Estradiol
Dosage form INSERT, EXTENDED RELEASE
Route VAGINAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA204305
Marketing category ANDA
Marketing start 2021-01-19
Marketing end 2027-07-31
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
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204305-001 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 2026-08-18 06:07:40 2026-07 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204305-001 ETHINYL ESTRADIOL; ETONOGESTREL 0.015MG/24HR;0.12MG/24HR RING / VAGINAL AB 2021-01-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Etonogestrel and Ethinyl Estradiol 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 · 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 0093-7679-01 Etonogestrel and Ethinyl Estradiol 21 d in 1 POUCH INSERT, EXTENDED RELEASE 21 5 0093-7679-02 Etonogestrel and Ethinyl Estradiol 3 in 1 CARTON INSERT, EXTENDED RELEASE 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-7679 ETONOGESTREL AND ETHINYL ESTRADIOL INSERT, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20221101_a8cc104a-d522-49ad-af54-2f312b829b61.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.
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 0093-7679-01 00093767901 21 d in 1 POUCH 21 d Historical 0093-7679-02 00093767902 3 POUCH in 1 CARTON (0093-7679-02) / 21 d in 1 POUCH (0093-7679-01) 3 pouch 2021-01-19 2027-07-31 No No Current