medroxyprogesterone acetate

Product NDC
59762-3740
Requested package NDC
59762-3740-5
11-digit product format
597623740
Labeler code
59762
Product ID
59762-3740_79175bd0-479f-4b42-b7f3-35a7fb840192
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
medroxyprogesterone acetate
Dosage form
TABLET
Route
ORAL
Labeler
Greenstone LLC
Application
NDA011839
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1959-06-03
Marketing end
2023-01-31
Substance
MEDROXYPROGESTERONE ACETATE
Active strength
3 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

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 packagepackage59762-374059762-3740-5DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N011839-001PROVERA2.5MGTABLET / 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011839-003PROVERA5MGTABLET / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011839-004PROVERA10MGTABLET / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N011839-001PROVERA2.5MGTABLET / ORALABRLD, Approved before 19821e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011839-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011839-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N011839-001AB11e350fbaab3a…

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-3740-1EA - Each59762-3740299323d8-e9c6-42fe-a833-5dd18c8ac8de12012-07-24
59762-3740-5EA - Each59762-3740282c5ee9-6dbe-4ff8-b54d-5a4858c4faed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]6
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]6
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]6
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]6
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]6
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]6
SUCROSEINACTIVE INGREDIENTC151H8M554MEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UMEDROXYPROGESTERONE ACETATE TABLET [PD-RX PHARMACEUTICALS, INC.]6
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LMEDROXYPROGESTERONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEDROXYPROGESTERONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMEDROXYPROGESTERONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMEDROXYPROGESTERONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BMEDROXYPROGESTERONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554MEDROXYPROGESTERONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMEDROXYPROGESTERONE ACETATE TABLET [PHYSICIANS TOTAL CARE, INC.]1

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
1000114medroxyPROGESTERone acetate 10 MG Oral TabletPSN499051ac-ffaf-4db4-be45-a409bd54991f1
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSN1b67cd36-7199-42ff-a8a7-cecc816796761
1000135medroxyPROGESTERone acetate 2.5 MG Oral TabletPSN499051ac-ffaf-4db4-be45-a409bd54991f1
1000141medroxyPROGESTERone acetate 5 MG Oral TabletPSN499051ac-ffaf-4db4-be45-a409bd54991f1
1000114medroxyprogesterone acetate 10 MG Oral TabletSCD499051ac-ffaf-4db4-be45-a409bd54991f1
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCD1b67cd36-7199-42ff-a8a7-cecc816796761
1000135medroxyprogesterone acetate 2.5 MG Oral TabletSCD499051ac-ffaf-4db4-be45-a409bd54991f1
1000141medroxyprogesterone acetate 5 MG Oral TabletSCD499051ac-ffaf-4db4-be45-a409bd54991f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-3740-5597623740051 BOTTLE in 1 CARTON (59762-3740-5) > 1000 TABLET in 1 BOTTLE1 bottle1959-06-032022-05-31NoNoCurrent