Megestrol Acetate

Product NDC: 0555-0607
11-digit product format: 005550607
Labeler code: 0555
Product ID: 0555-0607_6f22887e-a442-4505-bd99-00042e4075c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Megestrol Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA074621
Marketing category: ANDA
Marketing start: 1995-11-30
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074621-001	MEGESTROL ACETATE	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB		1995-11-30
A074621-002	MEGESTROL ACETATE	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB		1996-08-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074621-001	AB
A074621-002	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 3 · 84 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	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A074621-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074621-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074621-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074621-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074621-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074621-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074621-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074621-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074621-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074621-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074621-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074621-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074621-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074621-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074621-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074621-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074621-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074621-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074621-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074621-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074621-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074621-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074621-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074621-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074621-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074621-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074621-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074621-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074621-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074621-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074621-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074621-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074621-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074621-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074621-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074621-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074621-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074621-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074621-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074621-002	AB	1	`bb7c543d1eb4…`

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
66573d39-f2a7-49fd-9ed2-97ac8f6e8456	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
0555-0607-02	Megestrol Acetate	100 in 1 BOTTLE	TABLET	100		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0555-0607-02	EA - Each	0555-0607	a11adede-d92f-4882-8273-bf73c794be2c	1	2013-02-13
0555-0607-04	EA - Each	0555-0607	6c559447-57ba-402c-82d1-efa74aae2da8	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MEGESTROL ACETATE	ACTIVE INGREDIENT	TJ2M0FR8ES	MEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]	5
MEGESTROL	ACTIVE MOIETY	EA6LD1M70M	MEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]	5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	MEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	MEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0555-0607	MEGESTROL ACETATE TABLET [TEVA PHARMACEUTICALS USA, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20250119_66573d39-f2a7-49fd-9ed2-97ac8f6e8456.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Megestrol Acetate	MEGESTROL ACETATE	Bryant Ranch Prepack	9b764cf3-4756-4f0e-b747-421d71674313	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074621 application number: ANDA074621
Megestrol Acetate	MEGESTROL ACETATE	Teva Pharmaceuticals USA, Inc.	66573d39-f2a7-49fd-9ed2-97ac8f6e8456	2022-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074621 application number: ANDA074621 ndc (product): 0555-0607

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
860215	megestrol acetate 20 MG Oral Tablet	PSN	66573d39-f2a7-49fd-9ed2-97ac8f6e8456	12
860221	megestrol acetate 40 MG Oral Tablet	PSN	66573d39-f2a7-49fd-9ed2-97ac8f6e8456	12
860215	megestrol acetate 20 MG Oral Tablet	SCD	66573d39-f2a7-49fd-9ed2-97ac8f6e8456	12
860221	megestrol acetate 40 MG Oral Tablet	SCD	66573d39-f2a7-49fd-9ed2-97ac8f6e8456	12
860221	megestrol acetate 40 MG Oral Tablet	PSN	9b764cf3-4756-4f0e-b747-421d71674313	1
860221	megestrol acetate 40 MG Oral Tablet	SCD	9b764cf3-4756-4f0e-b747-421d71674313	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0555-0607-02	00555060702	100 TABLET in 1 BOTTLE (0555-0607-02)	100 tablet	1995-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Megestrol Acetate Tablets USP 0606 0607 Rx only	Bryant Ranch Prepack	2025-01-17	HUMAN PRESCRIPTION DRUG LABEL	1
Megestrol Acetate Tablets, USP Rx only	Teva Pharmaceuticals USA, Inc.	2022-11-30	HUMAN PRESCRIPTION DRUG LABEL	12