Home NDC 64380-158 Megestrol Acetate
Product NDC 64380-158
11-digit product format 643800158
Labeler code 64380
Product ID 64380-158_0eff5604-5d6a-4e95-9a10-db18fb8046b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Megestrol Acetate
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA072422
Marketing category ANDA
Marketing start 2022-04-11
Substance MEGESTROL ACETATE
Active strength 20 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 1 .
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 A072422-001 MEGESTROL ACETATE MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072422-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072422-001 MEGESTROL ACETATE 20MG TABLET / ORAL AB 1988-08-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 20 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860215 Internal RxNorm lookup 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 64380-158-01 Megestrol Acetate 100 in 1 BOTTLE TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-158 MEGESTROL ACETATE TABLET [STRIDES PHARMA SCIENCE LIMITED] 3 Current NDC, Legacy NDC, 1 package rows 20250226_8ec70070-da70-4a38-9d58-cf2278517661.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 · 1 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 64380-158-01 64380015801 100 TABLET in 1 BOTTLE (64380-158-01) 100 tablet 2022-04-11 0000-00-00 No No Current