Home NDC 69238-1252 Lopreeza
Product NDC 69238-1252
11-digit product format 692381252
Labeler code 69238
Product ID 69238-1252_16c8c503-117a-47cf-9770-b7c5185e20cf
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 AUTHORIZED GENERIC
Marketing start 2014-10-01
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 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ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28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N020907-002 ACTIVELLA 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2006-12-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020907-001 ACTIVELLA 1MG;0.5MG TABLET / ORAL AB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 9S44LIC7OJ Internal UNII lookup 4TI98Z838E 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 69238-1252-6 Lopreeza 28 in 1 DIALPACK TABLET, FILM COATED 28 19 69238-1252-6 Lopreeza 1 in 1 CARTON TABLET, FILM COATED 1 19 69238-1252-8 Lopreeza 5 in 1 CELLO PACK TABLET, FILM COATED 5 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESTRADIOL ACTIVE INGREDIENT 4TI98Z838E LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 NORETHINDRONE ACETATE ACTIVE INGREDIENT 9S44LIC7OJ LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 ESTRADIOL ACTIVE MOIETY 4TI98Z838E LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 NORETHINDRONE ACTIVE MOIETY T18F433X4S LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1252 LOPREEZA (ESTRADIOL/NORETHINDRONE ACETATE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] 19 Current NDC, Legacy NDC, 3 package rows 20231231_bf0e39cb-95e7-4831-92d2-0b3f071aeaae.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 Marketing end Sample Exclude flag Status 69238-1252-6 69238125206 28 in 1 DIALPACK Historical 69238-1252-8 69238125208 5 CARTON in 1 CELLO PACK (69238-1252-8) / 1 DIALPACK in 1 CARTON (69238-1252-6) / 28 TABLET, FILM COATED in 1 DIALPACK 5 carton 2014-10-01 0000-00-00 No No Current