Megestrol Acetate

Product NDC
17856-0907
11-digit product format
178560907
Labeler code
17856
Product ID
17856-0907_fd49b26a-ea53-4acc-9f35-4757e1da0b2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA075671
Marketing category
ANDA
Marketing start
2001-07-25
Marketing end
0000-00-00
Substance
MEGESTROL ACETATE
Active strength
40 mg/mL
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0907DDiscontinued by firm2026-08-17
excluded packagepackage17856-090717856-0907-1DDiscontinued by firm2026-08-17
excluded packagepackage17856-090717856-0907-2DDiscontinued by firm2026-08-17
excluded packagepackage17856-090717856-0907-3DDiscontinued by firm2026-08-17
excluded packagepackage17856-090717856-0907-5DDiscontinued by firm2026-08-17

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 · 15 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0907-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0907-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0907-5DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0907-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0907-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0907-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0907-5DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0907-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0907-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0907-2IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0907-3IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0907-5IInactivated by FDA1332a3947898…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075671-001MEGESTROL ACETATEMEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075671-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALAB2001-07-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALAB2001-07-253f01610625f2…
2019-09-15 20:21 UTC2019-09A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALAB2001-07-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALAB2001-07-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075671-001MEGESTROL ACETATE40MG/MLSUSPENSION / ORALABRS2001-07-25e64feba35796…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075671-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075671-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075671-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075671-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075671-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075671-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075671-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075671-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075671-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075671-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075671-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075671-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075671-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075671-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075671-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075671-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075671-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075671-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075671-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075671-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075671-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075671-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075671-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075671-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075671-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075671-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075671-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075671-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075671-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075671-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075671-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075671-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075671-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075671-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075671-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075671-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075671-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075671-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075671-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075671-001AB1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0907-2ML - Milliliter17856-0907343c7c1b-6932-479f-a0b4-f849d98280b212013-02-13
17856-0907-3ML - Milliliter17856-09070e399487-8ca2-4647-936b-cd632d7552aa12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEGESTROL ACETATEACTIVE INGREDIENTTJ2M0FR8ESMEGESTROL ACETATE SUSPENSION [ATLANTIC BIOLOGICALS CORPS]4
MEGESTROLACTIVE MOIETYEA6LD1M70MMEGESTROL ACETATE SUSPENSION [ATLANTIC BIOLOGICALS CORPS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0907MEGESTROL ACETATE SUSPENSION [ATLANTIC BIOLOGICALS CORP.]8Legacy NDC20240511_239dacec-8c96-4f4d-878a-b9681cb390f3.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Megestrol AcetateMEGESTROL ACETATEATLANTIC BIOLOGICALS CORP.01119031-9943-4afb-8b45-cb71682f04822026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075671
application number: ANDA075671
Megestrol AcetateMEGESTROL ACETATEPreferred Pharmaceuticals Inc.edef65d1-d583-4cee-bb9a-515be84ac51d2026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075671
application number: ANDA075671
Megestrol AcetateMEGESTROL ACETATENatco Pharma USA LLC582cff8a-1def-43d6-ba7e-dce49e3e9f272026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075671
application number: ANDA075671
Megestrol AcetateMEGESTROL ACETATEKesin Pharma Corporation3bc8708e-a52d-fda2-e063-6294a90a0fbc2025-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075671
application number: ANDA075671
Megestrol AcetateMEGESTROL ACETATEPAI Holdings, LLC dba PAI Pharma46622697-2c51-44d5-9f1f-e48f8526f1322025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075671
application number: ANDA075671
Megestrol AcetateMEGESTROL ACETATEGolden State Medical Supply, Inc.19c33213-7919-208d-e063-6394a90a0f082024-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075671
application number: ANDA075671
Megestrol AcetateMEGESTROL ACETATEPrecision Dose Inc.bf0d54c5-b813-4f2e-9a37-cbea332cfe532024-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075671
application number: ANDA075671
Megestrol AcetateMEGESTROL ACETATEPrecision Dose Inc.d0ad931e-4e3e-48bf-9949-77d6971da6e62024-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075671
application number: ANDA075671
Megestrol AcetateMEGESTROL ACETATEStrides Pharma Science Limited9f7365a0-67cf-45fc-a914-e40a4507a0632022-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075671
application number: ANDA075671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0907-11785609070148 SYRINGE in 1 BOX, UNIT-DOSE (17856-0907-1) > 10 mL in 1 SYRINGE48 syringe2021-01-200000-00-00NoNoCurrent
17856-0907-21785609070220 mL in 1 CUP (17856-0907-2) 20 ml2021-01-200000-00-00NoNoCurrent
17856-0907-31785609070310 mL in 1 CUP (17856-0907-3) 10 ml2021-01-200000-00-00NoNoCurrent
17856-0907-5178560907055 mL in 1 SYRINGE (17856-0907-5) 5 ml2021-01-200000-00-00NoNoCurrent