Megestrol Acetate

Product NDC: 60432-126
Requested package NDC: 60432-126-16
11-digit product format: 604320126
Labeler code: 60432
Product ID: 60432-126_a697441b-aafb-4be7-bc29-b16071fed1cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: megestrol acetate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Morton Grove Pharmaceuticals, Inc.
Application: ANDA076721
Marketing category: ANDA
Marketing start: 2005-02-09
Marketing end: 0000-00-00
Substance: MEGESTROL ACETATE
Active strength: 40 mg/mL
Pharmacologic classes: Progesterone Congeners [CS],Progestin [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60432-126	60432-126-16	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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A076721-001	MEGESTROL ACETATE	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB		2004-11-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076721-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2004-11-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076721-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2004-11-01	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076721-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076721-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076721-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076721-001	AB	1	`6a471c1ec25d…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076721-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076721-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076721-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076721-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076721-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076721-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076721-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076721-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076721-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076721-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076721-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076721-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076721-001	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076721-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076721-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076721-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076721-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076721-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076721-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076721-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076721-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076721-001	AB	1	`a50c72e98297…`

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
60432-126-08	2023-01-30	C162847	48780-1	f386c64a-1d47-0266-e053-dadaa90a7c1a	MEGESTROL ACETATE ORAL SUSPENSION, USP 40 mg/mL
60432-126-16	2023-01-30	C162847	48780-1	f386c64a-1d47-0266-e053-dadaa90a7c1a	MEGESTROL ACETATE ORAL SUSPENSION, USP 40 mg/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60432-126-08	Megestrol Acetate	240 mL in 1 BOTTLE, PLASTIC	SUSPENSION	240		12
60432-126-16	Megestrol Acetate	480 mL in 1 BOTTLE, PLASTIC	SUSPENSION	480		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60432-126-08	ML - Milliliter	60432-126	24a62932-eda0-4781-a8a5-4bd733b60f3e	1	2012-07-24
60432-126-16	ML - Milliliter	60432-126	309972a2-4d78-4064-9a09-bc0988bb02e5	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 [MORTON GROVE PHARMACEUTICALS, INC.]	4
Megestrol	ACTIVE MOIETY	EA6LD1M70M	MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Poloxamer 124	INACTIVE INGREDIENT	1S66E28KXA	MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Trisodium Citrate Dihydrate	INACTIVE INGREDIENT	B22547B95K	MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]	4
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]	4
MEGESTROL ACETATE	ACTIVE INGREDIENT	TJ2M0FR8ES	MEGESTROL ACETATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	2
MEGESTROL	ACTIVE MOIETY	EA6LD1M70M	MEGESTROL ACETATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60432-126	MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.]	12	Legacy NDC, 2 package rows	20200718_eea3f3e0-ca3a-4f5d-8185-d52944b67e7a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Megestrol Acetate	MEGESTROL ACETATE	Xttrium Laboratories, Inc.	3169f883-4076-32ce-e063-6394a90a4925	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076721 application number: ANDA076721

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	eea3f3e0-ca3a-4f5d-8185-d52944b67e7a	12
860225	megestrol acetate 40 MG/ML Oral Suspension	SCD	eea3f3e0-ca3a-4f5d-8185-d52944b67e7a	12
860225	megestrol acetate 40 MG per 1 ML Oral Suspension	SY	eea3f3e0-ca3a-4f5d-8185-d52944b67e7a	12
860225	megestrol acetate 400 MG per 10 ML Oral Suspension	SY	eea3f3e0-ca3a-4f5d-8185-d52944b67e7a	12
860225	megestrol acetate 800 MG per 20 ML Oral Suspension	SY	eea3f3e0-ca3a-4f5d-8185-d52944b67e7a	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60432-126-16	60432012616	480 mL in 1 BOTTLE, PLASTIC (60432-126-16)	480 ml	2005-02-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Megestrol Acetate Oral Suspension USP 40 mg/mL	Pharmaceutical Associates, Inc. \| Morton Grove Pharmaceuticals, Inc.	2022-11-29	HUMAN PRESCRIPTION DRUG LABEL	13
MEGESTROL ACETATE ORAL SUSPENSION, USP 40 mg/mL	Morton Grove Pharmaceuticals, Inc.	2020-06-10	HUMAN PRESCRIPTION DRUG LABEL	12