Home NDC 59651-425-28 Etyqa
Product NDC 59651-425
Requested package NDC 59651-425-28
11-digit product format 596510425
Labeler code 59651
Product ID 59651-425_50c8c596-e201-4370-8487-421925c60b4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESTRADIOL AND NORETHINDRONE ACETATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA214729
Marketing category ANDA
Marketing start 2023-06-30
Substance ESTRADIOL; NORETHINDRONE ACETATE
Active strength .5; .1 mg/1; mg/1
Pharmacologic classes Estradiol Congeners [CS], 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214729-001 ETYQA ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL 2023-06-30 A214729-002 ETYQA ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2023-06-30
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 · 42 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 2026-02-19 14:30 UTC 2026-02 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214729-001 ETYQA 0.5MG;0.1MG TABLET / ORAL 2023-06-30 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214729-002 ETYQA 1MG;0.5MG TABLET / ORAL 2023-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214729-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2023-06-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A214729-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2023-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214729-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2023-06-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214729-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2023-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214729-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2023-06-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214729-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2023-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214729-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2023-06-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214729-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2023-06-30 a67488948f0b…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Etyqa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL .5 mg/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 4TI98Z838E Internal UNII lookup 9S44LIC7OJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1359123 Internal RxNorm lookup 1359124 Internal RxNorm lookup 1359126 Internal RxNorm lookup 1359127 Internal RxNorm lookup 2642136 Internal RxNorm lookup 2642137 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 59651-425-28 Etyqa 28 in 1 BLISTER PACK TABLET, FILM COATED 28 2 59651-425-28 Etyqa 1 in 1 CARTON TABLET, FILM COATED 1 2 59651-425-87 Etyqa 1 in 1 POUCH TABLET, FILM COATED 1 2 59651-425-87 Etyqa 1 in 1 CARTON TABLET, FILM COATED 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-425 ETYQA (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 Current NDC, 4 package rows 20240308_afbc2a33-5eb2-4f01-91e9-07d8050da6ce.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 Sample Exclude flag Status 59651-425-28 59651042528 1 BLISTER PACK in 1 CARTON (59651-425-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2023-06-30 No No Current