Home NDC 24979-041 Megestrol Acetate
Product NDC 24979-041
11-digit product format 249790041
Labeler code 24979
Product ID 24979-041_85b17cc1-0b8d-47a1-9d00-597920cdb7b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Megestrol Acetate
Dosage form SUSPENSION
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA203139
Marketing category ANDA
Marketing start 2015-03-01
Substance MEGESTROL ACETATE
Active strength 125 mg/mL
Pharmacologic classes Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A203139-001 MEGESTROL ACETATE MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL RS 2014-08-27
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 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL RS 2014-08-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL RS 2014-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL RS 2014-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL RS 2014-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL RS 2014-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203139-001 MEGESTROL ACETATE 125MG/ML SUSPENSION / ORAL AB 2014-08-27 e64feba35796…
Observed Orange Book normalized TE history# 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 125 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 577154 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 24979-041-13 Megestrol Acetate 150 mL in 1 BOTTLE SUSPENSION 150 19 24979-041-35 Megestrol Acetate 35 mL in 1 BOTTLE SUSPENSION 35 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEGESTROL ACETATE ACTIVE INGREDIENT TJ2M0FR8ES MEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.] 4 MEGESTROL ACTIVE MOIETY EA6LD1M70M MEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.] 4 ALCOHOL INACTIVE INGREDIENT 3K9958V90M MEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU MEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 MEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.] 4 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K MEGESTROL ACETATE (MEGESTROL ACETATE) SUSPENSION [TWI PHARMACEUTICALS, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24979-041 MEGESTROL ACETATE SUSPENSION [UPSHER-SMITH LABORATORIES, LLC] 15 Current NDC, Legacy NDC, 2 package rows 20250326_2dc921d5-e423-4379-a345-151e87d13651.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 24979-041-13 24979004113 150 mL in 1 BOTTLE (24979-041-13) 150 ml 2015-07-28 0000-00-00 No No Current 24979-041-35 24979004135 35 mL in 1 BOTTLE (24979-041-35) 35 ml 2025-12-01 No No Current