FDA.reportPublic FDA data

MEDROXYPROGESTERONE ACETATE

Product NDC
69097-539
Requested package NDC
69097-539-31
11-digit product format
690970539
Labeler code
69097
Product ID
69097-539_3b389352-a6a3-45ea-9335-b3df361f7d87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEDROXYPROGESTERONE ACETATE
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Cipla USA Inc.
Application
ANDA210335
Marketing category
ANDA
Marketing start
2019-01-25
Marketing end
0000-00-00
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
150 mg/mL
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69097-53969097-539-31DDiscontinued by firm2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210335-001MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-2584e616aacf4f…
2026-08-18 06:07:402026-07A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-253f01610625f2…
2019-09-15 20:21 UTC2019-09A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2019-01-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210335-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTION2019-01-25f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A210335-001AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-539MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [CIPLA USA INC.]4Legacy NDC20210317_3d033fba-6313-4906-9d34-245423eaeeef.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-539-31690970539311 VIAL, SINGLE-DOSE in 1 CARTON (69097-539-31) > 1 mL in 1 VIAL, SINGLE-DOSE2019-01-250000-00-00NoNoCurrent