Home NDC 71335-2544 Megestrol Acetate
Product NDC 71335-2544
11-digit product format 713352544
Labeler code 71335
Product ID 71335-2544_8b804ecd-ba91-455f-aa51-9f77446fdbc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Megestrol Acetate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA074621
Marketing category ANDA
Marketing start 1995-11-30
Substance MEGESTROL ACETATE
Active strength 40 mg/1
Pharmacologic classes Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074621-001 MEGESTROL ACETATE MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 A074621-002 MEGESTROL ACETATE MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074621-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB 1995-11-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074621-002 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1996-08-16 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Megestrol Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEGESTROL ACETATE 40 mg/1
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 860221 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 71335-2544-1 Megestrol Acetate 30 in 1 BOTTLE TABLET 30 1 71335-2544-2 Megestrol Acetate 100 in 1 BOTTLE TABLET 100 1 71335-2544-3 Megestrol Acetate 15 in 1 BOTTLE TABLET 15 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2544 MEGESTROL ACETATE TABLET [BRYANT RANCH PREPACK] 1 Current NDC, 3 package rows 20250119_9b764cf3-4756-4f0e-b747-421d71674313.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 Sample Exclude flag Status 71335-2544-1 71335254401 30 TABLET in 1 BOTTLE (71335-2544-1) 30 tablet 2025-01-17 No No Current 71335-2544-2 71335254402 100 TABLET in 1 BOTTLE (71335-2544-2) 100 tablet 2025-01-17 No No Current 71335-2544-3 71335254403 15 TABLET in 1 BOTTLE (71335-2544-3) 15 tablet 2025-01-17 No No Current