Home NDC 49884-290 Megestrol Acetate
Product NDC 49884-290
11-digit product format 498840290
Labeler code 49884
Product ID 49884-290_8707d220-fcf6-4b48-ae5f-1fdb44addcb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Megestrol Acetate
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA072423
Marketing category ANDA
Marketing start 1988-08-08
Marketing end 2024-12-31
Substance MEGESTROL ACETATE
Active strength 40 mg/1
Pharmacologic classes Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 38 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A072423-001 MEGESTROL ACETATE MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 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 A072423-001 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 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072423-001 MEGESTROL ACETATE 40MG TABLET / ORAL AB RS 1988-08-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEGESTROL ACETATE ACTIVE INGREDIENT TJ2M0FR8ES MEGESTROL ACETATE TABLET [PAR PHARMACEUTICAL INC] 5 MEGESTROL ACTIVE MOIETY EA6LD1M70M MEGESTROL ACETATE TABLET [PAR PHARMACEUTICAL INC] 5 MEGESTROL ACETATE ACTIVE INGREDIENT TJ2M0FR8ES MEGESTROL ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 MEGESTROL ACETATE ACTIVE INGREDIENT TJ2M0FR8ES MEGESTROL ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MEGESTROL ACTIVE MOIETY EA6LD1M70M MEGESTROL ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MEGESTROL ACTIVE MOIETY EA6LD1M70M MEGESTROL ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 ACACIA INACTIVE INGREDIENT 5C5403N26O MEGESTROL ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 ACACIA INACTIVE INGREDIENT 5C5403N26O MEGESTROL ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP MEGESTROL ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MEGESTROL ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MEGESTROL ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MEGESTROL ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MEGESTROL ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MEGESTROL ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MEGESTROL ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MEGESTROL ACETATE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MEGESTROL ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.] 4 MEGESTROL ACETATE ACTIVE INGREDIENT TJ2M0FR8ES MEGESTROL ACETATE TABLET [MAJOR PHARMACEUTICALS] 2 Megestrol Acetate ACTIVE INGREDIENT TJ2M0FR8ES MEGESTROL ACETATE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 MEGESTROL ACTIVE MOIETY EA6LD1M70M MEGESTROL ACETATE TABLET [MAJOR PHARMACEUTICALS] 2 Megestrol ACTIVE MOIETY EA6LD1M70M MEGESTROL ACETATE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP MEGESTROL ACETATE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MEGESTROL ACETATE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 MEGESTROL ACETATE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MEGESTROL ACETATE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MEGESTROL ACETATE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 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 · 3 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 49884-290-01 49884029001 100 TABLET in 1 BOTTLE (49884-290-01) 100 tablet 1988-08-08 0000-00-00 No No Current 49884-290-04 49884029004 250 TABLET in 1 BOTTLE (49884-290-04) 250 tablet 1988-08-08 0000-00-00 No No Current 49884-290-05 49884029005 500 TABLET in 1 BOTTLE (49884-290-05) 500 tablet 1988-08-08 0000-00-00 No No Current