FDA.reportPublic FDA data

MENEST

Product NDC
61570-075
11-digit product format
615700075
Labeler code
61570
Product ID
61570-075_e2bbaf86-ad94-4452-a6a5-80e70dd351e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esterified estrogens
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
ANDA084949
Marketing category
ANDA
Marketing start
2018-09-17
Marketing end
0000-00-00
Substance
ESTROGENS, ESTERIFIED
Active strength
3 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61570-075DDiscontinued by firm2026-08-17
excluded packagepackage61570-07561570-075-50DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084949-001MENESTESTROGENS, ESTERIFIED2.5MGTABLET / ORALApproved before 1982

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A084949-001MENEST2.5MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A084949-001MENEST2.5MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084949-001MENEST2.5MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A084949-001MENEST2.5MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084949-001MENEST2.5MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084949-001MENEST2.5MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084949-001MENEST2.5MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084949-001MENEST2.5MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084949-001MENEST2.5MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084949-001MENEST2.5MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084949-001MENEST2.5MGTABLET / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084949-001MENEST2.5MGTABLET / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084949-001MENEST2.5MGTABLET / ORALRS, Approved before 1982e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
aaaf3f1f-0ca7-2c75-a463-4dc624538feeProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61570-075-50EA - Each61570-075932fd63a-a5de-4358-883c-5926a6d3e64012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTROGENS, ESTERIFIEDACTIVE INGREDIENT3ASP8Q3768MENEST (ESTERIFIED ESTROGENS) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]6
ESTROGENS, ESTERIFIEDACTIVE MOIETY3ASP8Q3768MENEST (ESTERIFIED ESTROGENS) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61570-075MENEST (ESTERIFIED ESTROGENS) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]15Legacy NDC20240227_e0141598-0bb2-4cf0-c9b8-6867b34bbb17.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61570-075-506157000755050 TABLET, FILM COATED in 1 BOTTLE (61570-075-50) 2018-09-170000-00-00NoNoCurrent