Megestrol Acetate

Product NDC: 68788-8714
Requested package NDC: 68788-8714-2
11-digit product format: 687888714
Labeler code: 68788
Product ID: 68788-8714_06743d22-d4e5-4543-9b01-e33febeba791
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Megestrol Acetate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA075671
Marketing category: ANDA
Marketing start: 2024-07-12
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 1.

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 · 41 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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075671-001	AB	1	`cb3db0bc1861…`

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	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
edef65d1-d583-4cee-bb9a-515be84ac51d	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	Strength	SPL version
68788-8714-2	Megestrol Acetate	240 mL in 1 BOTTLE, PLASTIC	SUSPENSION	240		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8714-2	ML - Milliliter	68788-8714	65c7339f-fa9b-4d54-95f0-24cb4d24b4d8	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8714	MEGESTROL ACETATE SUSPENSION [PREFERRED PHARMACEUTICALS INC.]	1	Current NDC, 1 package rows	20240727_edef65d1-d583-4cee-bb9a-515be84ac51d.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 ndc (package): 68788-8714-2 ndc (product): 68788-8714 ndc11 (package): 68788871402
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	edef65d1-d583-4cee-bb9a-515be84ac51d	2
860225	megestrol acetate 40 MG/ML Oral Suspension	SCD	edef65d1-d583-4cee-bb9a-515be84ac51d	2
860225	megestrol acetate 40 MG per 1 ML Oral Suspension	SY	edef65d1-d583-4cee-bb9a-515be84ac51d	2
860225	megestrol acetate 400 MG per 10 ML Oral Suspension	SY	edef65d1-d583-4cee-bb9a-515be84ac51d	2
860225	megestrol acetate 800 MG per 20 ML Oral Suspension	SY	edef65d1-d583-4cee-bb9a-515be84ac51d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8714-2	68788871402	240 mL in 1 BOTTLE, PLASTIC (68788-8714-2)	240 ml	2024-07-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEGESTROL ACETATE ORAL SUSPENSION, USP	Preferred Pharmaceuticals Inc.	2026-06-15	HUMAN PRESCRIPTION DRUG LABEL	3