Megestrol Acetate

Product NDC: 33358-903
11-digit product format: 333580903
Labeler code: 33358
Product ID: 33358-903_3c02f4fb-2d20-3529-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Megestrol Acetate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Rxchange Co
Application: ANDA075671
Marketing category: ANDA
Marketing start: 2001-07-25
Marketing end: 0000-00-00
Substance: MEGESTROL ACETATE
Active strength: 40 mg/mL
Pharmacologic classes: Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33358-903		I	Inactivated by FDA	2026-08-17
excluded package	package	33358-903	33358-903-05	I	Inactivated by FDA	2026-08-17
excluded package	package	33358-903	33358-903-10	I	Inactivated by FDA	2026-08-17
excluded package	package	33358-903	33358-903-20	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 2 · 88 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33358-903-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33358-903-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33358-903-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33358-903-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33358-903-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33358-903-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33358-903-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33358-903-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33358-903-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33358-903-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33358-903-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33358-903-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33358-903-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33358-903-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33358-903-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33358-903-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33358-903-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33358-903-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33358-903-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33358-903-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33358-903-20	`302b2466d912…`	`e7b80fea0513…`
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	33358-903-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33358-903-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33358-903-20	`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	33358-903-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33358-903-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33358-903-20	`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	33358-903-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33358-903-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33358-903-20	`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	33358-903-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33358-903-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33358-903-20	`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	33358-903-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33358-903-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33358-903-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33358-903-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33358-903-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33358-903-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33358-903-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33358-903-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33358-903-20	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33358-903-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33358-903-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33358-903-20	`1332a3947898…`	`d4bfe170f9cd…`

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
A075671-001	MEGESTROL ACETATE	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075671-001	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 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	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB		2001-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB		2001-07-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB		2001-07-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB		2001-07-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075671-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075671-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075671-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075671-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075671-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075671-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075671-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075671-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075671-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075671-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075671-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075671-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075671-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075671-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075671-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075671-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075671-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075671-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075671-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075671-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075671-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075671-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075671-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075671-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075671-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075671-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075671-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075671-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075671-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075671-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075671-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075671-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075671-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075671-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075671-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075671-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075671-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075671-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075671-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075671-001	AB	1	`e64feba35796…`

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
33358-903-05	2020-01-31	C162847	48780-1	9d75b9d1-2754-f424-e053-dadaa90a57ce	3c02f4fb-2d1f-3529-e054-00144ff88e88
33358-903-10	2020-01-31	C162847	48780-1	9d75b9d1-2754-f424-e053-dadaa90a57ce	3c02f4fb-2d1f-3529-e054-00144ff88e88
33358-903-20	2020-01-31	C162847	48780-1	9d75b9d1-2754-f424-e053-dadaa90a57ce	3c02f4fb-2d1f-3529-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33358-903-05	Megestrol Acetate	5 mL in 1 CUP, UNIT-DOSE	SUSPENSION	5	1
33358-903-10	Megestrol Acetate	10 mL in 1 CUP, UNIT-DOSE	SUSPENSION	10	1
33358-903-20	Megestrol Acetate	20 mL in 1 CUP, UNIT-DOSE	SUSPENSION	20	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33358-903-10	ML - Milliliter	33358-903	f236f82f-8dbf-43ae-ab72-93271301f623	1	2016-10-06
33358-903-20	ML - Milliliter	33358-903	bd74eb77-1717-4ea3-9f0a-43d557a0f345	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33358-903	MEGESTROL ACETATE SUSPENSION [RXCHANGE CO]	1	Legacy NDC, 3 package rows	20160909_3c02f4fb-2d1f-3529-e054-00144ff88e88.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Megestrol Acetate	MEGESTROL ACETATE	ATLANTIC BIOLOGICALS CORP.	01119031-9943-4afb-8b45-cb71682f0482	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	Preferred Pharmaceuticals Inc.	edef65d1-d583-4cee-bb9a-515be84ac51d	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	Natco Pharma USA LLC	582cff8a-1def-43d6-ba7e-dce49e3e9f27	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	Kesin Pharma Corporation	3bc8708e-a52d-fda2-e063-6294a90a0fbc	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	PAI Holdings, LLC dba PAI Pharma	46622697-2c51-44d5-9f1f-e48f8526f132	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	Golden State Medical Supply, Inc.	19c33213-7919-208d-e063-6394a90a0f08	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	Precision Dose Inc.	bf0d54c5-b813-4f2e-9a37-cbea332cfe53	2024-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	Precision Dose Inc.	d0ad931e-4e3e-48bf-9949-77d6971da6e6	2024-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671
Megestrol Acetate	MEGESTROL ACETATE	Strides Pharma Science Limited	9f7365a0-67cf-45fc-a914-e40a4507a063	2022-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075671 application number: ANDA075671

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
860225	megestrol acetate 40 MG in 1 mL Oral Suspension	PSN	3c02f4fb-2d1f-3529-e054-00144ff88e88	1
860225	megestrol acetate 40 MG/ML Oral Suspension	SCD	3c02f4fb-2d1f-3529-e054-00144ff88e88	1
860225	megestrol acetate 40 MG per 1 ML Oral Suspension	SY	3c02f4fb-2d1f-3529-e054-00144ff88e88	1
860225	megestrol acetate 400 MG per 10 ML Oral Suspension	SY	3c02f4fb-2d1f-3529-e054-00144ff88e88	1
860225	megestrol acetate 800 MG per 20 ML Oral Suspension	SY	3c02f4fb-2d1f-3529-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
33358-903-05	33358090305	5 mL in 1 CUP, UNIT-DOSE	5 ml	Historical
33358-903-10	33358090310	10 mL in 1 CUP, UNIT-DOSE	10 ml	Historical
33358-903-20	33358090320	20 mL in 1 CUP, UNIT-DOSE	20 ml	Historical