Home NDC 79929-012 ESTRADIOL AND NORETHINDRONE ACETATE
Product NDC 79929-012
11-digit product format 799290012
Labeler code 79929
Product ID 79929-012_1a990fcf-1731-8ca1-e063-6294a90ac9c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol and norethindrone acetate
Dosage form TABLET
Route ORAL
Labeler Naari Pte. Limited
Application ANDA210233
Marketing category ANDA
Marketing start 2024-06-11
Substance NORETHINDRONE ACETATE; ESTRADIOL
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 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 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210233-001 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 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2018-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210233-001 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL 2018-02-28 f41ea6bd6efb…
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 ESTRADIOL AND NORETHINDRONE ACETATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NORETHINDRONE ACETATE .5 mg/1 ESTRADIOL 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9S44LIC7OJ Internal UNII lookup 4TI98Z838E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1359126 Internal RxNorm lookup 1359127 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 79929-012-07 ESTRADIOL AND NORETHINDRONE ACETATE 84 in 1 POUCH TABLET 84 5 79929-012-07 ESTRADIOL AND NORETHINDRONE ACETATE 28 in 1 BLISTER PACK TABLET 28 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79929-012 ESTRADIOL AND NORETHINDRONE ACETATE TABLET [NAARI PTE. LIMITED] 5 Current NDC, 2 package rows 20240612_f70185fe-9fcf-655f-e053-6394a90a20dc.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 79929-012-07 79929001207 84 BLISTER PACK in 1 POUCH (79929-012-07) / 28 TABLET in 1 BLISTER PACK 84 blister pack 2024-06-11 No No Current