Home NDC 60432-126 Megestrol Acetate
Product NDC 60432-126
11-digit product format 604320126
Labeler code 60432
Product ID 60432-126_a697441b-aafb-4be7-bc29-b16071fed1cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name megestrol acetate
Dosage form SUSPENSION
Route ORAL
Labeler Morton Grove Pharmaceuticals, Inc.
Application ANDA076721
Marketing category ANDA
Marketing start 2005-02-09
Marketing end 0000-00-00
Substance MEGESTROL ACETATE
Active strength 40 mg/mL
Pharmacologic classes Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 45 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 A076721-001 MEGESTROL ACETATE MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076721-001 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 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL 2004-11-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076721-001 MEGESTROL ACETATE 40MG/ML SUSPENSION / ORAL AB 2004-11-01 e64feba35796…
Observed Orange Book normalized TE history# 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 60432-126-08 Megestrol Acetate 240 mL in 1 BOTTLE, PLASTIC SUSPENSION 240 12 60432-126-16 Megestrol Acetate 480 mL in 1 BOTTLE, PLASTIC SUSPENSION 480 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEGESTROL ACETATE ACTIVE INGREDIENT TJ2M0FR8ES MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 4 Megestrol ACTIVE MOIETY EA6LD1M70M MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 4 Anhydrous Citric Acid INACTIVE INGREDIENT XF417D3PSL MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 4 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 4 Poloxamer 124 INACTIVE INGREDIENT 1S66E28KXA MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 4 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 4 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 4 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 4 Trisodium Citrate Dihydrate INACTIVE INGREDIENT B22547B95K MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 4 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 4 MEGESTROL ACETATE ACTIVE INGREDIENT TJ2M0FR8ES MEGESTROL ACETATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 MEGESTROL ACTIVE MOIETY EA6LD1M70M MEGESTROL ACETATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60432-126 MEGESTROL ACETATE SUSPENSION [MORTON GROVE PHARMACEUTICALS, INC.] 12 Legacy NDC, 2 package rows 20200718_eea3f3e0-ca3a-4f5d-8185-d52944b67e7a.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 60432-126-08 60432012608 240 mL in 1 BOTTLE, PLASTIC (60432-126-08) 240 ml 2005-02-09 0000-00-00 No No Current 60432-126-16 60432012616 480 mL in 1 BOTTLE, PLASTIC (60432-126-16) 480 ml 2005-02-09 0000-00-00 No No Current