Megestrol Acetate

Product NDC: 0116-4011
11-digit product format: 001164011
Labeler code: 0116
Product ID: 0116-4011_3aae2aec-a959-8e66-e063-6294a90a8f46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Megestrol Acetate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Xttrium Laboratories, Inc.
Application: ANDA076721
Marketing category: ANDA
Marketing start: 2025-03-28
Substance: MEGESTROL ACETATE
Active strength: 40 mg/mL
Pharmacologic classes: Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Megestrol Acetate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEGESTROL ACETATE	40 mg/mL

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
3169f883-4076-32ce-e063-6394a90a4925	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
078c5235-b5d8-c448-12aa-7c7688d21da3	Product name	3	20180205
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
1bec0d29-4d8b-21df-403d-4848e3aaa3bc	Product name	2	20170725
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
0116-4011-08	Megestrol Acetate	237 mL in 1 BOTTLE, PLASTIC	SUSPENSION	237	2
0116-4011-10	Megestrol Acetate	10 mL in 1 CUP, UNIT-DOSE	SUSPENSION	10	2
0116-4011-11	Megestrol Acetate	10 in 1 TRAY	SUSPENSION	10	2
0116-4011-11	Megestrol Acetate	10 in 1 CASE	SUSPENSION	10	2
0116-4011-16	Megestrol Acetate	480 mL in 1 BOTTLE, PLASTIC	SUSPENSION	480	2
0116-4011-30	Megestrol Acetate	10 in 1 TRAY	SUSPENSION	10	2
0116-4011-30	Megestrol Acetate	30 in 1 CASE	SUSPENSION	30	2
0116-4011-40	Megestrol Acetate	10 in 1 TRAY	SUSPENSION	10	2
0116-4011-40	Megestrol Acetate	40 in 1 CASE	SUSPENSION	40	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0116-4011	MEGESTROL ACETATE SUSPENSION [XTTRIUM LABORATORIES, INC.]	1	Current NDC, 9 package rows	20250503_3169f883-4076-32ce-e063-6394a90a4925.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 ndc (product): 0116-4011

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	3169f883-4076-32ce-e063-6394a90a4925	2
860225	megestrol acetate 40 MG/ML Oral Suspension	SCD	3169f883-4076-32ce-e063-6394a90a4925	2
860225	megestrol acetate 40 MG per 1 ML Oral Suspension	SY	3169f883-4076-32ce-e063-6394a90a4925	2
860225	megestrol acetate 400 MG per 10 ML Oral Suspension	SY	3169f883-4076-32ce-e063-6394a90a4925	2
860225	megestrol acetate 800 MG per 20 ML Oral Suspension	SY	3169f883-4076-32ce-e063-6394a90a4925	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0116-4011-08	00116401108	237 mL in 1 BOTTLE, PLASTIC (0116-4011-08)	237 ml	2025-03-28	No	No	Current
0116-4011-10	00116401110	10 mL in 1 CUP, UNIT-DOSE	10 ml				Historical
0116-4011-11	00116401111	10 TRAY in 1 CASE (0116-4011-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)	10 tray	2025-03-28	No	No	Current
0116-4011-16	00116401116	480 mL in 1 BOTTLE, PLASTIC (0116-4011-16)	480 ml	2025-03-28	No	No	Current
0116-4011-30	00116401130	30 TRAY in 1 CASE (0116-4011-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)	30 tray	2025-03-28	No	No	Current
0116-4011-40	00116401140	40 TRAY in 1 CASE (0116-4011-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)	40 tray	2025-03-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Megestrol Acetate Oral Suspension, USP 40 mg/mL	Xttrium Laboratories, Inc.	2025-07-24	HUMAN PRESCRIPTION DRUG LABEL	2