medroxyprogesterone acetate

Product NDC
68788-9233
11-digit product format
687889233
Labeler code
68788
Product ID
68788-9233_91b3473d-b95b-4b7d-a1d4-3ff2cb75a9b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
medroxyprogesterone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Preferred Pharmaceuticals, Inc
Application
NDA020246
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1992-10-29
Marketing end
0000-00-00
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
150 mg/mL
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-9233IInactivated by FDA2026-08-17
excluded packagepackage68788-923368788-9233-1IInactivated by FDA2026-08-17

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-9233-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-9233-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-9233-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-9233-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-9233-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-9233-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-9233-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-9233-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-9233-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-9233-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-9233-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-9233-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68788-9233-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68788-9233-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68788-9233-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68788-9233-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68788-9233-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68788-9233-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68788-9233-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68788-9233-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68788-9233-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68788-9233-1110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020246-001DEPO-PROVERAMEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020246-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-293f01610625f2…
2019-09-15 20:21 UTC2019-09N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020246-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020246-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020246-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020246-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020246-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020246-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020246-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020246-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020246-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020246-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020246-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020246-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020246-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020246-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020246-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020246-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020246-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020246-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020246-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020246-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020246-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020246-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020246-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020246-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020246-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020246-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020246-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020246-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020246-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020246-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020246-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020246-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020246-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020246-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020246-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020246-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020246-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020246-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020246-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020246-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9233-1medroxyprogesterone acetate1 mL in 1 VIALINJECTION, SUSPENSION17

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9233MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [PREFERRED PHARMACEUTICALS, INC]7Legacy NDC, 1 package rows20111121_91b3473d-b95b-4b7d-a1d4-3ff2cb75a9b9.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEPrasco Laboratories987496bf-b4b0-409b-b745-f52ed0871f4e2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020246
application number: NDA020246
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions5e817926-ba15-4d16-9463-88f6ff3bd3ac2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020246
application number: NDA020246
Depo-ProveraMEDROXYPROGESTERONE ACETATEPharmacia & Upjohn Company LLC199cf13e-0859-4a73-9b45-e700d0cd10492025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020246
application number: NDA020246
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutionsca344c55-5251-470f-9243-eceb9e496e3e2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020246
application number: NDA020246

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000126medroxyPROGESTERone acetate 150 MG in 1 ML InjectionPSN91b3473d-b95b-4b7d-a1d4-3ff2cb75a9b97
10001261 ML medroxyprogesterone acetate 150 MG/ML InjectionSCD91b3473d-b95b-4b7d-a1d4-3ff2cb75a9b97
1000126medroxyprogesterone acetate 150 MG per 1 ML InjectionSY91b3473d-b95b-4b7d-a1d4-3ff2cb75a9b97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68788-9233-1687889233011 mL in 1 VIAL1 mlHistorical