Home NDC 0904-7577 Megestrol Acetate
Product NDC 0904-7577
11-digit product format 009047577
Labeler code 0904
Product ID 0904-7577_1843fe79-7628-4f8e-9b51-e0be7562e43d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Megestrol Acetate
Dosage form SUSPENSION
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA077404
Marketing category ANDA
Marketing start 2025-12-29
Substance MEGESTROL ACETATE
Active strength 400 mg/10mL
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 A077404-001 MEGESTROL ACETATE MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077404-001 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 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2006-02-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077404-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2006-02-16 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 400 mg/10mL
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-7577-18 Megestrol Acetate 4 in 1 CASE SUSPENSION 4 2 0904-7577-18 Megestrol Acetate 10 in 1 TRAY SUSPENSION 10 2 0904-7577-66 Megestrol Acetate 10 mL in 1 CUP, UNIT-DOSE SUSPENSION 10 2 0904-7577-72 Megestrol Acetate 10 in 1 TRAY SUSPENSION 10 2 0904-7577-72 Megestrol Acetate 10 in 1 CASE SUSPENSION 10 2
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0904-7577-18 00904757718 4 TRAY in 1 CASE (0904-7577-18) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7577-66) 4 tray 2026-01-15 No No Current 0904-7577-66 00904757766 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 0904-7577-72 00904757772 10 TRAY in 1 CASE (0904-7577-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7577-66) 10 tray 2025-12-29 No No Current