Home NDC 69238-1609 LOPREEZA
Product NDC 69238-1609
11-digit product format 692381609
Labeler code 69238
Product ID 69238-1609_617a2d78-e850-4965-a23a-b0eacd0541a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol/norethindrone acetate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application NDA020907
Marketing category NDA
Marketing start 2019-01-07
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 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69238-1609-6 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69238-1609-6 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69238-1609-6 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69238-1609-6 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69238-1609-6 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N020907-001 ACTIVELLA ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 N020907-002 ACTIVELLA ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020907-001 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 3 · 86 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 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020907-002 ACTIVELLA 0.5MG;0.1MG TABLET / ORAL RLD 2006-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020907-002 ACTIVELLA 0.5MG;0.1MG TABLET / ORAL RLD 2006-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020907-002 ACTIVELLA 0.5MG;0.1MG TABLET / ORAL RLD 2006-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB RLD, RS 1998-11-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020907-002 ACTIVELLA 0.5MG;0.1MG TABLET / ORAL AB RLD 2006-12-28 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 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 LOPREEZA
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 1550964 Internal RxNorm lookup 1550965 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 69238-1609-6 LOPREEZA 28 in 1 BLISTER PACK TABLET, FILM COATED 28 10 69238-1609-6 LOPREEZA 1 in 1 CARTON TABLET, FILM COATED 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1609 LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] 10 Current NDC, Legacy NDC, 2 package rows 20250124_966ac064-9eb7-4d15-b271-a7880ed1e79a.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 · 3 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 69238-1609-6 69238160906 1 BLISTER PACK in 1 CARTON (69238-1609-6) / 28 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2019-01-07 No No Current