Megestrol Acetate

Product NDC: 17856-0060
Requested package NDC: 17856-0060-3
11-digit product format: 178560060
Labeler code: 17856
Product ID: 17856-0060_35ced36e-d65c-4dca-e063-6294a90ae85c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Megestrol Acetate
Dosage form: SUSPENSION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA075671
Marketing category: ANDA
Marketing start: 2022-03-21
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0060	17856-0060-3	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 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	A075671-001	MEGESTROL ACETATE	40MG/ML	SUSPENSION / ORAL	AB	RS	2001-07-25	`caaa826d4ba7…`
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…`

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	A075671-001	AB	1	`caaa826d4ba7…`
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…`

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
01119031-9943-4afb-8b45-cb71682f0482	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
078c5235-b5d8-c448-12aa-7c7688d21da3	Product name	3	20180205
1bec0d29-4d8b-21df-403d-4848e3aaa3bc	Product name	2	20170725
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
056e8b65-29c9-affb-3d52-7651668fe36b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
17856-0060-3	2024-05-09	MEGESTROL ACETATE ORAL SUSPENSION, USP
17856-0060-3	2024-05-09	MEGESTROL ACETATE ORAL SUSPENSION, USP
17856-0060-4	2024-05-09	MEGESTROL ACETATE ORAL SUSPENSION, USP
17856-0060-4	2024-05-09	MEGESTROL ACETATE ORAL SUSPENSION, USP
17856-0060-3	2024-01-30	MEGESTROL ACETATE ORAL SUSPENSION, USP
17856-0060-3	2024-01-30	MEGESTROL ACETATE ORAL SUSPENSION, USP
17856-0060-4	2024-01-30	MEGESTROL ACETATE ORAL SUSPENSION, USP
17856-0060-4	2024-01-30	MEGESTROL ACETATE ORAL SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-0060-1	Megestrol Acetate	10 mL in 1 CUP	SUSPENSION	10	3
17856-0060-2	Megestrol Acetate	20 mL in 1 CUP	SUSPENSION	20	3
17856-0060-3	Megestrol Acetate	72 in 1 BOX	SUSPENSION	72	3
17856-0060-4	Megestrol Acetate	50 in 1 BOX	SUSPENSION	50	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0060	MEGESTROL ACETATE SUSPENSION [ATLANTIC BIOLOGICALS CORP.]	3	Current NDC, Legacy NDC, 4 package rows	20250524_01119031-9943-4afb-8b45-cb71682f0482.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 ndc (package): 17856-0060-3 ndc (product): 17856-0060 ndc11 (package): 17856006003
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
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	01119031-9943-4afb-8b45-cb71682f0482	3
860225	megestrol acetate 40 MG/ML Oral Suspension	SCD	01119031-9943-4afb-8b45-cb71682f0482	3
860225	megestrol acetate 40 MG per 1 ML Oral Suspension	SY	01119031-9943-4afb-8b45-cb71682f0482	3
860225	megestrol acetate 400 MG per 10 ML Oral Suspension	SY	01119031-9943-4afb-8b45-cb71682f0482	3
860225	megestrol acetate 800 MG per 20 ML Oral Suspension	SY	01119031-9943-4afb-8b45-cb71682f0482	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0060-3	17856006003	72 CUP in 1 BOX (17856-0060-3) / 10 mL in 1 CUP (17856-0060-1)	72 cup	2024-05-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEGESTROL ACETATE ORAL SUSPENSION, USP	ATLANTIC BIOLOGICALS CORP.	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	4