Megestrol Acetate

Product NDC: 0904-7577
Requested package NDC: 0904-7577-18
11-digit product format: 009047577
Labeler code: 0904
Product ID: 0904-7577_1843fe79-7628-4f8e-9b51-e0be7562e43d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Megestrol Acetate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA077404
Marketing category: ANDA
Marketing start: 2025-12-29
Substance: MEGESTROL ACETATE
Active strength: 400 mg/10mL
Pharmacologic classes: Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077404-001	MEGESTROL ACETATE	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB		2006-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077404-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	2006-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077404-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL		2006-02-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077404-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077404-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077404-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077404-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077404-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077404-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077404-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077404-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077404-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077404-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077404-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077404-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077404-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077404-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077404-001	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077404-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Megestrol Acetate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEGESTROL ACETATE	400 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TJ2M0FR8ES	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860225	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e44cf173-991b-43cf-93f2-e0efaa4cc29a	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-7577-18	Megestrol Acetate	4 in 1 CASE	SUSPENSION	4	2
0904-7577-18	Megestrol Acetate	10 in 1 TRAY	SUSPENSION	10	2
0904-7577-66	Megestrol Acetate	10 mL in 1 CUP, UNIT-DOSE	SUSPENSION	10	2
0904-7577-72	Megestrol Acetate	10 in 1 TRAY	SUSPENSION	10	2
0904-7577-72	Megestrol Acetate	10 in 1 CASE	SUSPENSION	10	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7577-18	ML - Milliliter	0904-7577	428b9fa4-ee7e-4a59-b922-170745977587	1	2026-02-05
0904-7577-66	ML - Milliliter	0904-7577	91989707-c7e8-4371-8dda-fec52a698768	1	2026-02-05
0904-7577-72	ML - Milliliter	0904-7577	a5a455d8-6bba-44fb-864c-5fa3173e1f38	1	2026-02-05

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Megestrol Acetate	MEGESTROL ACETATE	Major Pharmaceuticals	e44cf173-991b-43cf-93f2-e0efaa4cc29a	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077404 application number: ANDA077404 ndc (package): 0904-7577-18 ndc (product): 0904-7577 ndc11 (package): 00904757718
Megestrol Acetate	MEGESTROL ACETATE	American Health Packaging	2921731a-6866-4dc8-8f6b-b636abf7bcf8	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077404 application number: ANDA077404
Megestrol Acetate	MEGESTROL ACETATE	PAI Holdings, LLC dba PAI Pharma	2d5b58cd-cbb1-4f5c-b13f-63185c0f8e31	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077404 application number: ANDA077404
Megestrol Acetate	MEGESTROL ACETATE	ANI Pharmaceuticals, Inc.	a26dcd78-ad62-4cf5-ad97-49ccb34d43ba	2024-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077404 application number: ANDA077404

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	e44cf173-991b-43cf-93f2-e0efaa4cc29a	2
860225	megestrol acetate 40 MG/ML Oral Suspension	SCD	e44cf173-991b-43cf-93f2-e0efaa4cc29a	2
860225	megestrol acetate 40 MG per 1 ML Oral Suspension	SY	e44cf173-991b-43cf-93f2-e0efaa4cc29a	2
860225	megestrol acetate 400 MG per 10 ML Oral Suspension	SY	e44cf173-991b-43cf-93f2-e0efaa4cc29a	2
860225	megestrol acetate 800 MG per 20 ML Oral Suspension	SY	e44cf173-991b-43cf-93f2-e0efaa4cc29a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7577-18	00904757718	4 TRAY in 1 CASE (0904-7577-18) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7577-66)	4 tray	2026-01-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Megestrol Acetate Oral Suspension USP, 40 mg/ml Rx Only	Major Pharmaceuticals	2026-01-15	HUMAN PRESCRIPTION DRUG LABEL	2