Megace ES

Product NDC: 17856-0949
11-digit product format: 178560949
Labeler code: 17856
Product ID: 17856-0949_bcb4eb8f-40da-47b5-9061-dbc973467acb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: megesterol acetate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Atlantic Biologicals Corps
Application: NDA021778
Marketing category: NDA
Marketing start: 2005-07-02
Marketing end: 0000-00-00
Substance: MEGESTROL ACETATE
Active strength: 125 mg/mL
Pharmacologic classes: Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	17856-0949		I	Inactivated by FDA		2026-08-17
excluded package	package	17856-0949	17856-0949-5	I	Inactivated by FDA		2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0949-5	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0949-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0949-5	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0949-5	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0949-5	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0949-5	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0949-5	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0949-5	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0949-5	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0949-5	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0949-5	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0949-5	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0949-5	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0949-5	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0949-5	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	17856-0949-5	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	17856-0949-5	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	17856-0949-5	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	17856-0949-5	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	17856-0949-5	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	17856-0949-5	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	17856-0949-5	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021778-001	MEGACE ES	MEGESTROL ACETATE	125MG/ML	SUSPENSION / ORAL		RLD	2005-07-05

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL		RLD	2005-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL		RLD	2005-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL		RLD	2005-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL		RLD	2005-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL		RLD	2005-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021778-001	MEGACE ES	125MG/ML	SUSPENSION / ORAL	AB	RLD, RS	2005-07-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021778-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021778-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021778-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021778-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021778-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021778-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021778-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021778-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021778-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021778-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021778-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021778-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021778-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021778-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021778-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021778-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021778-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021778-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021778-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021778-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021778-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021778-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021778-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021778-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021778-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021778-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021778-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021778-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021778-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021778-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021778-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021778-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021778-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021778-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021778-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021778-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 181 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021778-001	7101576	2024-04-22	U-755			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021778-001	9040088	2024-04-22	U-755		2015-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021778-001	9101540	2024-04-22	U-755	Drug product	2015-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021778-001	9101549	2024-04-22	U-755		2015-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021778-001	9107827	2024-04-22	U-755		2015-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021778-001	7101576	2024-04-22	U-755			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021778-001	9040088	2024-04-22	U-755		2015-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021778-001	9101540	2024-04-22	U-755	Drug product	2015-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021778-001	9101549	2024-04-22	U-755		2015-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021778-001	9107827	2024-04-22	U-755		2015-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021778-001	7101576	2024-04-22	U-755			`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021778-001	9040088	2024-04-22	U-755		2015-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021778-001	9101540	2024-04-22	U-755	Drug product	2015-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021778-001	9101549	2024-04-22	U-755		2015-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021778-001	9107827	2024-04-22	U-755		2015-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021778-001	7101576	2024-04-22	U-755			`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021778-001	9040088	2024-04-22	U-755		2015-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021778-001	9101540	2024-04-22	U-755	Drug product	2015-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021778-001	9101549	2024-04-22	U-755		2015-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021778-001	9107827	2024-04-22	U-755		2015-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021778-001	7101576	2024-04-22	U-755			`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021778-001	9040088	2024-04-22	U-755		2015-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021778-001	9101540	2024-04-22	U-755	Drug product	2015-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021778-001	9101549	2024-04-22	U-755		2015-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021778-001	9107827	2024-04-22	U-755		2015-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021778-001	7101576	2024-04-22	U-755			`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021778-001	9040088	2024-04-22	U-755		2015-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021778-001	9101540	2024-04-22	U-755	Drug product	2015-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021778-001	9101549	2024-04-22	U-755		2015-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021778-001	9107827	2024-04-22	U-755		2015-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021778-001	7101576	2024-04-22	U-755			`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021778-001	9040088	2024-04-22	U-755		2015-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021778-001	9101540	2024-04-22	U-755	Drug product	2015-08-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021778-001	9101549	2024-04-22	U-755		2015-08-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021778-001	9107827	2024-04-22	U-755		2015-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021778-001	7101576	2024-04-22	U-755			`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021778-001	9040088	2024-04-22	U-755		2015-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021778-001	9101540	2024-04-22	U-755	Drug product	2015-08-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021778-001	9101549	2024-04-22	U-755		2015-08-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021778-001	9107827	2024-04-22	U-755		2015-08-27	`1e350fbaab3a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
078c5235-b5d8-c448-12aa-7c7688d21da3	Product name	3	20180205
1bec0d29-4d8b-21df-403d-4848e3aaa3bc	Product name	2	20170725
056e8b65-29c9-affb-3d52-7651668fe36b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0949-5	2020-01-31	C162847	48780-1	9d75b9d0-cb68-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Megace ES safely and effectively. See full prescribing information for Megace ES. Megace ES (megestrol acetate, USP) Oral Suspension Initial U.S. Approval: 1993 ® ® ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0949-5	Megace ES	5 mL in 1 CUP	SUSPENSION	5		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEGESTROL ACETATE	ACTIVE INGREDIENT	TJ2M0FR8ES	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3
MEGESTROL	ACTIVE MOIETY	EA6LD1M70M	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3
LEMON	INACTIVE INGREDIENT	24RS0A988O	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3
LIME (CITRUS)	INACTIVE INGREDIENT	8CZS546954	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0949	MEGACE ES (MEGESTEROL ACETATE) SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	3	Legacy NDC, 1 package rows	20140821_654854bc-f847-4e3b-a0a1-8716553460ac.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TJ2M0FR8ES	MEGESTROL ACETATE	595-33-5	MEGESTROL ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
885111	MEGACE ES 625 MG in 5 mL Oral Suspension	PSN	654854bc-f847-4e3b-a0a1-8716553460ac	3
577154	megestrol acetate 625 MG in 5 mL Oral Suspension	PSN	654854bc-f847-4e3b-a0a1-8716553460ac	3
885111	megestrol acetate 125 MG/ML Oral Suspension [Megace]	SBD	654854bc-f847-4e3b-a0a1-8716553460ac	3
577154	megestrol acetate 125 MG/ML Oral Suspension	SCD	654854bc-f847-4e3b-a0a1-8716553460ac	3
885111	Megace ES 125 MG/ML Oral Suspension	SY	654854bc-f847-4e3b-a0a1-8716553460ac	3
885111	Megace ES 625 MG per 5 ML Oral Suspension	SY	654854bc-f847-4e3b-a0a1-8716553460ac	3
577154	megestrol acetate 625 MG per 5 ML Oral Suspension	SY	654854bc-f847-4e3b-a0a1-8716553460ac	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
17856-0949-5	17856094905	5 mL in 1 CUP	5 ml	Historical