medroxyprogesterone acetate

Product NDC
69189-3740
11-digit product format
691893740
Labeler code
69189
Product ID
69189-3740_8e565f0a-ed52-46f9-9638-88a41edbf6b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
medroxyprogesterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA011839
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-02-02
Marketing end
0000-00-00
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
3 mg/1
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct69189-3740IInactivated by FDA2026-10-05
excluded packagepackage69189-374069189-3740-1IInactivated by FDA2026-10-05

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69189-3740-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69189-3740-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69189-3740-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69189-3740-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69189-3740-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69189-3740-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69189-3740-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69189-3740-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69189-3740-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69189-3740-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69189-3740-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69189-3740-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69189-3740-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69189-3740-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69189-3740-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69189-3740-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69189-3740-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69189-3740-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69189-3740-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69189-3740-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69189-3740-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69189-3740-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N011839-001PROVERAMEDROXYPROGESTERONE ACETATE2.5MGTABLET / ORALABRLD, Approved before 1982
N011839-003PROVERAMEDROXYPROGESTERONE ACETATE5MGTABLET / ORALABRLD, Approved before 1982
N011839-004PROVERAMEDROXYPROGESTERONE ACETATE10MGTABLET / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N011839-001AB
N011839-003AB
N011839-004AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 1982301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N011839-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N011839-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N011839-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N011839-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N011839-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N011839-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N011839-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011839-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011839-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011839-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011839-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011839-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N011839-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011839-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011839-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011839-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011839-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011839-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011839-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011839-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011839-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011839-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011839-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011839-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011839-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011839-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011839-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011839-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011839-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011839-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011839-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011839-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011839-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N011839-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N011839-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N011839-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011839-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011839-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011839-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011839-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69189-3740-12020-01-31C16284748780-19d75b9cf-d2cb-f424-e053-dadaa90a57ceMedroxyprogesterone Acetate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-3740-1medroxyprogesterone acetate1 in 1 DOSE PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-3740MEDROXYPROGESTERONE ACETATE TABLET [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20170412_1b67cd36-7199-42ff-a8a7-cecc81679676.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProveraMEDROXYPROGESTERONE ACETATEPharmacia & Upjohn Company LLCa586be28-96af-4fed-a13f-9b94fd4c74052026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 011839
application number: NDA011839
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEMylan Pharmaceuticals Inc.2627eb11-06bf-4a45-9172-094468e3ca072026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 011839
application number: NDA011839

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSN1b67cd36-7199-42ff-a8a7-cecc816796761
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCD1b67cd36-7199-42ff-a8a7-cecc816796761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-3740-1691893740011 in 1 DOSE PACKHistorical