Megestrol Acetate

Product NDC
63629-2221
11-digit product format
636292221
Labeler code
63629
Product ID
63629-2221_961fab3a-ee27-4801-8a4a-98fa03c72b27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021778
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-07-28
Marketing end
2023-05-31
Substance
MEGESTROL ACETATE
Active strength
125 mg/mL
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct63629-2221DDiscontinued by firm2026-08-17
excluded packagepackage63629-222163629-2221-1DDiscontinued by firm2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-2221-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-2221-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-2221-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-2221-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-2221-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-2221-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-2221-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-2221-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-2221-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-2221-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-2221-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-2221-1557ba5c1ecfa…9c80585c8c6e…

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
N021778-001MEGACE ESMEGESTROL ACETATE125MG/MLSUSPENSION / ORALRLD2005-07-05

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 06:07:402026-07N021778-001MEGACE ES125MG/MLSUSPENSION / ORALRLD2005-07-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021778-001MEGACE ES125MG/MLSUSPENSION / ORALRLD2005-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021778-001MEGACE ES125MG/MLSUSPENSION / ORALRLD2005-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021778-001MEGACE ES125MG/MLSUSPENSION / ORALRLD2005-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021778-001MEGACE ES125MG/MLSUSPENSION / ORALRLD2005-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-053f01610625f2…
2019-09-15 20:21 UTC2019-09N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-053f0d92c62455…
2023-05-13 08:27 UTC2023-05N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05053a50430f4f…
2023-01-26 05:58 UTC2023-01N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021778-001MEGACE ES125MG/MLSUSPENSION / ORALABRLD, RS2005-07-05e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021778-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021778-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021778-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021778-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021778-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021778-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021778-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021778-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021778-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021778-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021778-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021778-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021778-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021778-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021778-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021778-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021778-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021778-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021778-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021778-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021778-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021778-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021778-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021778-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021778-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021778-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021778-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021778-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021778-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021778-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021778-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021778-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021778-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021778-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021778-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021778-001AB1cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 5 · 181 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021778-00171015762024-04-22U-75503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021778-00190400882024-04-22U-7552015-06-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021778-00191015402024-04-22U-755Drug product2015-08-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021778-00191015492024-04-22U-7552015-08-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021778-00191078272024-04-22U-7552015-08-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021778-00171015762024-04-22U-7552680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021778-00190400882024-04-22U-7552015-06-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021778-00191015402024-04-22U-755Drug product2015-08-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021778-00191015492024-04-22U-7552015-08-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021778-00191078272024-04-22U-7552015-08-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021778-00171015762024-04-22U-7555bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021778-00190400882024-04-22U-7552015-06-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021778-00191015402024-04-22U-755Drug product2015-08-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021778-00191015492024-04-22U-7552015-08-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021778-00191078272024-04-22U-7552015-08-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021778-00171015762024-04-22U-755d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021778-00190400882024-04-22U-7552015-06-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021778-00191015402024-04-22U-755Drug product2015-08-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021778-00191015492024-04-22U-7552015-08-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021778-00191078272024-04-22U-7552015-08-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021778-00171015762024-04-22U-755d06236e962d9…
2024-10-29 15:01 UTC2024-10N021778-00190400882024-04-22U-7552015-06-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N021778-00191015402024-04-22U-755Drug product2015-08-13d06236e962d9…
2024-10-29 15:01 UTC2024-10N021778-00191015492024-04-22U-7552015-08-13d06236e962d9…
2024-10-29 15:01 UTC2024-10N021778-00191078272024-04-22U-7552015-08-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021778-00171015762024-04-22U-75579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021778-00190400882024-04-22U-7552015-06-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021778-00191015402024-04-22U-755Drug product2015-08-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021778-00191015492024-04-22U-7552015-08-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021778-00191078272024-04-22U-7552015-08-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021778-00171015762024-04-22U-755301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021778-00190400882024-04-22U-7552015-06-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021778-00191015402024-04-22U-755Drug product2015-08-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021778-00191015492024-04-22U-7552015-08-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021778-00191078272024-04-22U-7552015-08-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021778-00171015762024-04-22U-7551e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021778-00190400882024-04-22U-7552015-06-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021778-00191015402024-04-22U-755Drug product2015-08-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021778-00191015492024-04-22U-7552015-08-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021778-00191078272024-04-22U-7552015-08-271e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2221-1ML - Milliliter63629-222172618b96-1a16-4f79-ba2c-75bbc9e97d5412021-05-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2221-163629222101150 mL in 1 BOTTLE (63629-2221-1) 150 ml2021-03-220000-00-00NoNoCurrent