Megestrol Acetate

Product NDC: 64380-159
11-digit product format: 643800159
Labeler code: 64380
Product ID: 64380-159_0eff5604-5d6a-4e95-9a10-db18fb8046b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Megestrol Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA072423
Marketing category: ANDA
Marketing start: 2022-04-04
Substance: MEGESTROL ACETATE
Active strength: 40 mg/1
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
A072423-001	MEGESTROL ACETATE	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072423-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072423-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	RS	1988-08-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A072423-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072423-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072423-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072423-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072423-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072423-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072423-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072423-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072423-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072423-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072423-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072423-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072423-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072423-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072423-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072423-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072423-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072423-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072423-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072423-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072423-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072423-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072423-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072423-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072423-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072423-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072423-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072423-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072423-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072423-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072423-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072423-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072423-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072423-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072423-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072423-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072423-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072423-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072423-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072423-001	AB	1	`e64feba35796…`

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/1

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860215	Internal RxNorm lookup
860221	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
8ec70070-da70-4a38-9d58-cf2278517661	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
64380-159-01	Megestrol Acetate	100 in 1 BOTTLE	TABLET	100	3
64380-159-02	Megestrol Acetate	250 in 1 BOTTLE	TABLET	250	3
64380-159-03	Megestrol Acetate	500 in 1 BOTTLE	TABLET	500	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-159-01	EA - Each	64380-159	592b5445-db90-4e33-95ac-88518619592c	1	2022-04-06
64380-159-02	EA - Each	64380-159	c59be506-eb60-44d1-9d14-f48f64e62190	1	2022-05-04
64380-159-03	EA - Each	64380-159	f8252de1-c993-4be6-9d03-eb27891f1829	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-159	MEGESTROL ACETATE TABLET [STRIDES PHARMA SCIENCE LIMITED]	3	Current NDC, Legacy NDC, 3 package rows	20250226_8ec70070-da70-4a38-9d58-cf2278517661.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Megestrol Acetate	MEGESTROL ACETATE	Major Pharmaceuticals	2c755c6b-32e9-4029-8b70-855007f7375b	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072423 application number: ANDA072423
Megestrol Acetate	MEGESTROL ACETATE	Bryant Ranch Prepack	dd6617df-0876-4fc5-8435-b53d29ccc1ae	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072423 application number: ANDA072423
Megestrol Acetate	MEGESTROL ACETATE	Strides Pharma Science Limited	8ec70070-da70-4a38-9d58-cf2278517661	2025-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072423 application number: ANDA072423 ndc (product): 64380-159

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
860221	megestrol acetate 40 MG Oral Tablet	PSN	dd6617df-0876-4fc5-8435-b53d29ccc1ae	102
860221	megestrol acetate 40 MG Oral Tablet	SCD	dd6617df-0876-4fc5-8435-b53d29ccc1ae	102
860215	megestrol acetate 20 MG Oral Tablet	PSN	8ec70070-da70-4a38-9d58-cf2278517661	3
860221	megestrol acetate 40 MG Oral Tablet	PSN	2c755c6b-32e9-4029-8b70-855007f7375b	3
860221	megestrol acetate 40 MG Oral Tablet	PSN	8ec70070-da70-4a38-9d58-cf2278517661	3
860215	megestrol acetate 20 MG Oral Tablet	SCD	8ec70070-da70-4a38-9d58-cf2278517661	3
860221	megestrol acetate 40 MG Oral Tablet	SCD	2c755c6b-32e9-4029-8b70-855007f7375b	3
860221	megestrol acetate 40 MG Oral Tablet	SCD	8ec70070-da70-4a38-9d58-cf2278517661	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64380-159-01	64380015901	100 TABLET in 1 BOTTLE (64380-159-01)	100 tablet	2022-04-04	0000-00-00	No	No	Current
64380-159-02	64380015902	250 TABLET in 1 BOTTLE (64380-159-02)	250 tablet	2022-04-04	0000-00-00	No	No	Current
64380-159-03	64380015903	500 TABLET in 1 BOTTLE (64380-159-03)	500 tablet	2022-04-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEGESTROL ACETATE TABLETS, USP	Major Pharmaceuticals	2025-09-15	HUMAN PRESCRIPTION DRUG LABEL	3
MEGESTROL ACETATE TABLETS, USP	Bryant Ranch Prepack	2025-03-31	HUMAN PRESCRIPTION DRUG LABEL	102
MEGESTROL ACETATE TABLETS, USP	Strides Pharma Science Limited \| Strides Pharma Global Pte. Ltd. \| Strides Pharma, Inc	2025-02-24	HUMAN PRESCRIPTION DRUG LABEL	3