Home NDC 72189-215 Junel FE
Product NDC 72189-215
11-digit product format 721890215
Labeler code 72189
Product ID 72189-215_4d3a9c67-ae9a-d4c1-e063-6394a90aff1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Junel FE
Dosage form TABLET
Route ORAL
Labeler Direct_Rx
Application ANDA076380
Marketing category ANDA
Marketing start 2021-10-06
Substance ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Active strength 20; 1 ug/1; mg/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 72189-215 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-215 72189-215-28 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 A076380-001 JUNEL 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076380-001 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.
Product history page 1 of 2 · 43 observed 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 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076380-001 JUNEL 1/20 0.02MG;1MG TABLET / ORAL-21 AB 2003-05-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 Junel FE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHINYL ESTRADIOL 20 ug/1 NORETHINDRONE ACETATE 1 mg/1
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 9S44LIC7OJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1358762 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 72189-215-28 Junel FE 28 in 1 POUCH TABLET 28 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-215 JUNEL FE TABLET [DIRECT_RX] 2 Current NDC, Legacy NDC, 1 package rows 20250119_ea62a66e-d45d-11be-e053-2a95a90a7801.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Junel FE JUNEL FE Direct_Rx ea62a66e-d45d-11be-e053-2a95a90a7801 2026-03-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076380 application number: ANDA076380 ndc (product): 72189-215 Junel 21 Day NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Teva Pharmaceuticals USA, Inc. 8b82ad14-580c-4145-b825-dce849f95363 2025-02-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076380 application number: ANDA076380 Loestrin Fe 28 Day NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE Teva Women's Health LLC f29ebcb5-7e65-4092-bfaa-f5ec026fc255 2025-02-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076380 application number: ANDA076380 Junel 21 Day NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL Proficient Rx LP 56e91ad4-f31b-494d-9e75-6dd4f396779c 2024-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076380 application number: ANDA076380
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 72189-215-28 72189021528 28 TABLET in 1 POUCH (72189-215-28) 28 tablet 2021-10-06 0000-00-00 No No Current