Megestrol Acetate

Product NDC: 0054-3542
11-digit product format: 000543542
Labeler code: 0054
Product ID: 0054-3542_c0981702-d861-4a62-a9d2-a716b65e9a20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Megestrol Acetate
Dosage form: SUSPENSION
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp.
Application: ANDA075997
Marketing category: ANDA
Marketing start: 2002-02-15
Marketing end: 2021-07-31
Substance: MEGESTROL ACETATE
Active strength: 40 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0054-3542		D	Discontinued by firm		2026-08-17
excluded package	package	0054-3542	0054-3542-58	D	Discontinued by firm		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 · 24 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	0054-3542-58	`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	0054-3542-58	`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	0054-3542-58	`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	0054-3542-58	`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	0054-3542-58	`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	0054-3542-58	`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	0054-3542-58	`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	0054-3542-58	`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	0054-3542-58	`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	0054-3542-58	`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	0054-3542-58	`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	0054-3542-58	`557ba5c1ecfa…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075997-001	MEGESTROL ACETATE	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15

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	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2002-02-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2002-02-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2002-02-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2002-02-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075997-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL			2002-02-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075997-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075997-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075997-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075997-001	AB	1	`ea99ee380514…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-3542-58	ML - Milliliter	0054-3542	fe474094-fc2c-45aa-9e8c-e4689443fb54	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEGESTROL ACETATE	ACTIVE INGREDIENT	TJ2M0FR8ES	MEGESTROL ACETATE SUSPENSION [ROXANE LABORATORIES, INC]	6
MEGESTROL	ACTIVE MOIETY	EA6LD1M70M	MEGESTROL ACETATE SUSPENSION [ROXANE LABORATORIES, INC]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MEGESTROL ACETATE SUSPENSION [ROXANE LABORATORIES, INC]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MEGESTROL ACETATE SUSPENSION [ROXANE LABORATORIES, INC]	6
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	MEGESTROL ACETATE SUSPENSION [ROXANE LABORATORIES, INC]	6
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	MEGESTROL ACETATE SUSPENSION [ROXANE LABORATORIES, INC]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	MEGESTROL ACETATE SUSPENSION [ROXANE LABORATORIES, INC]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	MEGESTROL ACETATE SUSPENSION [ROXANE LABORATORIES, INC]	6
MEGESTROL ACETATE	ACTIVE INGREDIENT	TJ2M0FR8ES	MEGESTOL (MEGESTROL ACETATE) SUSPENSION [STAT RX USA LLC]	1
MEGESTROL	ACTIVE MOIETY	EA6LD1M70M	MEGESTOL (MEGESTROL ACETATE) SUSPENSION [STAT RX USA LLC]	1

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	dd332944-d610-4338-9e5e-9b2e5e90e399	1
860225	megestrol acetate 40 MG/ML Oral Suspension	SCD	dd332944-d610-4338-9e5e-9b2e5e90e399	1
860225	megestrol acetate 40 MG per 1 ML Oral Suspension	SY	dd332944-d610-4338-9e5e-9b2e5e90e399	1
860225	megestrol acetate 400 MG per 10 ML Oral Suspension	SY	dd332944-d610-4338-9e5e-9b2e5e90e399	1
860225	megestrol acetate 800 MG per 20 ML Oral Suspension	SY	dd332944-d610-4338-9e5e-9b2e5e90e399	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-3542-58	00054354258	240 mL in 1 BOTTLE, PLASTIC (0054-3542-58)	240 ml	2002-02-15	2021-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Megestrol Acetate Oral Suspension USP	West-Ward Pharmaceuticals Corp. \| West-Ward Columbus Inc.	2019-07-23	HUMAN PRESCRIPTION DRUG LABEL	9
MEGESTOL - STAT RX USA LLC	STAT RX USA LLC	2010-01-22	HUMAN PRESCRIPTION DRUG LABEL	1