Megestrol Acetate

Product NDC
69339-160
Requested package NDC
69339-160-18
11-digit product format
693390160
Labeler code
69339
Product ID
69339-160_2de58bb1-eff3-471a-8760-7006d7c54030
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Megestrol Acetate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
ANDA075671
Marketing category
ANDA
Marketing start
2023-07-31
Substance
MEGESTROL ACETATE
Active strength
40 mg/mL
Pharmacologic classes
Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69339-16069339-160-18IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Megestrol Acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEGESTROL ACETATE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TJ2M0FR8ESInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860225Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
582cff8a-1def-43d6-ba7e-dce49e3e9f27Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
078c5235-b5d8-c448-12aa-7c7688d21da3Product name320180205
1bec0d29-4d8b-21df-403d-4848e3aaa3bcProduct name220170725
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
056e8b65-29c9-affb-3d52-7651668fe36bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-160-01Megestrol Acetate10 mL in 1 CUP, UNIT-DOSESUSPENSION102
69339-160-16Megestrol Acetate3 in 1 CASESUSPENSION32
69339-160-16Megestrol Acetate10 in 1 TRAYSUSPENSION102
69339-160-17Megestrol Acetate4 in 1 CASESUSPENSION42
69339-160-17Megestrol Acetate10 in 1 TRAYSUSPENSION102
69339-160-18Megestrol Acetate10 in 1 TRAYSUSPENSION102
69339-160-18Megestrol Acetate5 in 1 CASESUSPENSION52
69339-160-19Megestrol Acetate10 in 1 CASESUSPENSION102
69339-160-19Megestrol Acetate10 in 1 TRAYSUSPENSION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-160-01ML - Milliliter69339-16067edb6da-5e2c-4fcc-8a4a-3b098aaff6eb12023-09-05
69339-160-16ML - Milliliter69339-16027f6e6c7-08d3-442e-b959-3a663f18545312023-09-05
69339-160-17ML - Milliliter69339-16031b3dcc7-2913-4c24-b3a6-640158ec6c3712023-09-05
69339-160-18ML - Milliliter69339-16059fcc138-63c5-45d5-b946-93f453f5505612023-09-05
69339-160-19ML - Milliliter69339-160da7e552a-6eec-4c7f-993b-b3d609d66d9912023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-160MEGESTROL ACETATE SUSPENSION [NATCO PHARMA USA LLC]1Current NDC, 9 package rows20230825_582cff8a-1def-43d6-ba7e-dce49e3e9f27.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
ndc (package): 69339-160-18
ndc (product): 69339-160
ndc11 (package): 69339016018
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860225megestrol acetate 40 MG in 1 mL Oral SuspensionPSN582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 40 MG/ML Oral SuspensionSCD582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 40 MG per 1 ML Oral SuspensionSY582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 400 MG per 10 ML Oral SuspensionSY582cff8a-1def-43d6-ba7e-dce49e3e9f272
860225megestrol acetate 800 MG per 20 ML Oral SuspensionSY582cff8a-1def-43d6-ba7e-dce49e3e9f272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69339-160-18693390160185 TRAY in 1 CASE (69339-160-18) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-160-01) 5 tray2023-07-31NoNoCurrent