FDA.reportPublic FDA data

medroxyprogesterone acetate 2.5 MG Oral Tablet [Provera]

RxCUI
1000139
RxNorm name
medroxyprogesterone acetate 2.5 MG Oral Tablet [Provera]
Display name
PROVERA (Oral Pill)
Full name
medroxyprogesterone acetate 2.5 MG Oral Tablet [Provera]
Term type
SBD
Status
Active
Strength
2.5 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-21 07:26:37

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092010
Active start
092010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
medroxyprogesterone acetate2.5 MG / 1 EACHmedroxyprogesteronemedroxyprogesterone acetate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
medroxyprogesterone6691

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRProvera 2.5 MG Oral Tablet1NAMES
RxNorm Namemedroxyprogesterone acetate 2.5 MG Oral Tablet [Provera]1NAMES
RxNorm SynonymProvera 2.5 MG Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDa586be28-96af-4fed-a13f-9b94fd4c74051CODES
RxCUI10001391CODES
MMSL_CODEBD18441CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0009-0065-010009-0065Provera medroxyprogesterone acetatePharmacia & Upjohn Company LLCNDA011839

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0118390009-0065Provera medroxyprogesterone acetateNDAPharmacia & Upjohn Company LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 29 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00009006404rxnav_ndcsyes
00009006501rxnav_ndcsyes
55289012130rxnav_ndcsyes
00009006406rxnav_historical
00009006412rxnav_historical
00855331050rxnav_historical_indirect
11822526701rxnav_historical
49999027201rxnav_historical
49999027230rxnav_historical
51129006401rxnav_historical
53978335609rxnav_historical
54569184901rxnav_historical
54569184903rxnav_historical
54868101001rxnav_historical
54868101003rxnav_historical
54868101004rxnav_historical
55154391101rxnav_historical
58016096900rxnav_historical
58016096930rxnav_historical
58016096960rxnav_historical
58016096990rxnav_historical
58056027810rxnav_historical
60491054401rxnav_historical
60491054430rxnav_historical
62584006400rxnav_historical
65084015310rxnav_historical_indirect
65427006404rxnav_historical
65427006406rxnav_historical
68071077030rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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.

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
ndc (package): 0009-0065-01
ndc (product): 0009-0065
ndc11 (package): 00009006501
rxcui: 1000139

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
a586be28-96af-4fed-a13f-9b94fd4c7405Provera 2.5 MG Oral Tablet [PSN] · medroxyprogesterone acetate 2.5 MG Oral Tablet [Provera] [SBD] · Provera 2.5 MG Oral Tablet [SY]326PROVERA® (medroxyprogesterone acetate tablets, USP)20240830

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
a586be28-96af-4fed-a13f-9b94fd4c7405PROVERA® (medroxyprogesterone acetate tablets, USP)Pharmacia & Upjohn Company LLC | Pfizer Italia S.r.l.20260629
a586be28-96af-4fed-a13f-9b94fd4c7405PROVERA® (medroxyprogesterone acetate tablets, USP)Pharmacia & Upjohn Company LLC | Pfizer Italia S.r.l. | Pfizer Inc20240830
7be7727e-59cd-405e-985b-8fcbaf4c8dbeNational Council for Prescription Drug Programs20130213

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCG03DAPregnen (4) derivativesATC1-4medroxyprogesterone
ATCL02ABProgestogensATC1-4medroxyprogesterone
ATCG03ACProgestogensATC1-4medroxyprogesterone
FDASPLD045167Progesterone CongenersCHEMhas_chemical_structuremedroxyprogesterone
FDASPLN0000175602ProgestinEPChas_epcmedroxyprogesterone
MEDRTD008525MedroxyprogesteroneCHEMhas_ingredientmedroxyprogesterone
MEDRTD017258Medroxyprogesterone AcetateCHEMhas_ingredientmedroxyprogesterone acetate
MEDRTD000568AmenorrheaDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD000568AmenorrheaDISEASEmay_treatmedroxyprogesterone
MEDRTD001943Breast NeoplasmsDISEASEmay_treatmedroxyprogesterone
MEDRTD001943Breast NeoplasmsDISEASEci_withmedroxyprogesterone
MEDRTD001943Breast NeoplasmsDISEASEci_withmedroxyprogesterone acetate
MEDRTD001943Breast NeoplasmsDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD002292Carcinoma, Renal CellDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD002292Carcinoma, Renal CellDISEASEmay_treatmedroxyprogesterone
MEDRTD002543Cerebral HemorrhageDISEASEci_withmedroxyprogesterone acetate
MEDRTD002543Cerebral HemorrhageDISEASEci_withmedroxyprogesterone
MEDRTD004342Drug HypersensitivityDISEASEci_withmedroxyprogesterone acetate
MEDRTD004342Drug HypersensitivityDISEASEci_withmedroxyprogesterone
MEDRTD004714Endometrial HyperplasiaDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD004714Endometrial HyperplasiaDISEASEmay_treatmedroxyprogesterone
MEDRTD016889Endometrial NeoplasmsDISEASEmay_treatmedroxyprogesterone
MEDRTD016889Endometrial NeoplasmsDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD006470HemorrhageDISEASEci_withmedroxyprogesterone
MEDRTD006470HemorrhageDISEASEci_withmedroxyprogesterone acetate
MEDRTD007040HypoventilationDISEASEmay_treatmedroxyprogesterone
MEDRTD007040HypoventilationDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD008107Liver DiseasesDISEASEci_withmedroxyprogesterone acetate
MEDRTD008107Liver DiseasesDISEASEci_withmedroxyprogesterone
MEDRTD009376Neoplasms, Hormone-DependentDISEASEci_withmedroxyprogesterone acetate
MEDRTD009376Neoplasms, Hormone-DependentDISEASEci_withmedroxyprogesterone
MEDRTD011247PregnancyDISEASEmay_preventmedroxyprogesterone acetate
MEDRTD011247PregnancyDISEASEmay_preventmedroxyprogesterone
MEDRTD011247PregnancyDISEASEci_withmedroxyprogesterone
MEDRTD011247PregnancyDISEASEci_withmedroxyprogesterone acetate
MEDRTD011655Pulmonary EmbolismDISEASEci_withmedroxyprogesterone acetate
MEDRTD011655Pulmonary EmbolismDISEASEci_withmedroxyprogesterone
MEDRTD013924ThrombophlebitisDISEASEci_withmedroxyprogesterone acetate
MEDRTD013924ThrombophlebitisDISEASEci_withmedroxyprogesterone
MEDRTD014592Uterine HemorrhageDISEASEci_withmedroxyprogesterone
MEDRTD014592Uterine HemorrhageDISEASEci_withmedroxyprogesterone acetate
MEDRTD014592Uterine HemorrhageDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD014592Uterine HemorrhageDISEASEmay_treatmedroxyprogesterone
MEDRTD014623Vaginal DiseasesDISEASEci_withmedroxyprogesterone
MEDRTD014623Vaginal DiseasesDISEASEci_withmedroxyprogesterone acetate
MEDRTD020246Venous ThrombosisDISEASEci_withmedroxyprogesterone
MEDRTD020246Venous ThrombosisDISEASEci_withmedroxyprogesterone acetate
MEDRTN0000000185Progestational Hormone Receptor AgonistsMOAhas_moamedroxyprogesterone acetate
MEDRTN0000000185Progestational Hormone Receptor AgonistsMOAhas_moamedroxyprogesterone
MEDRTN0000008630Decreased Follicle Stimulating Hormone SecretionPEhas_pemedroxyprogesterone acetate
MEDRTN0000008630Decreased Follicle Stimulating Hormone SecretionPEhas_pemedroxyprogesterone
MEDRTN0000008632Decreased Growth Hormone SecretionPEhas_pemedroxyprogesterone acetate
MEDRTN0000008632Decreased Growth Hormone SecretionPEhas_pemedroxyprogesterone
MEDRTN0000009051Gonadotropin Releasing Hormone AlterationPEhas_pemedroxyprogesterone acetate
MEDRTN0000009051Gonadotropin Releasing Hormone AlterationPEhas_pemedroxyprogesterone
MEDRTN0000009715Inhibit Ovarian Follicular PhasePEhas_pemedroxyprogesterone acetate
MEDRTN0000009715Inhibit Ovarian Follicular PhasePEhas_pemedroxyprogesterone
MEDRTN0000009717Inhibit OvulationPEhas_pemedroxyprogesterone acetate
MEDRTN0000009717Inhibit OvulationPEhas_pemedroxyprogesterone
MEDRTN0000009857Stimulate Breast Glandular DevelopmentPEhas_pemedroxyprogesterone acetate
MEDRTN0000009857Stimulate Breast Glandular DevelopmentPEhas_pemedroxyprogesterone
MEDRTN0000000043Hepatic ExcretionPKhas_pkmedroxyprogesterone
MEDRTN0000000043Hepatic ExcretionPKhas_pkmedroxyprogesterone acetate
MEDRTN0000000026Hepatic MetabolismPKhas_pkmedroxyprogesterone
MEDRTN0000000026Hepatic MetabolismPKhas_pkmedroxyprogesterone acetate
MEDRTN0000000042Renal ExcretionPKhas_pkmedroxyprogesterone
MEDRTN0000000042Renal ExcretionPKhas_pkmedroxyprogesterone acetate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH2.5 MG (expressed as medroxyprogesterone acetate)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA011839
NAMESPrescribable SynonymProvera 2.5 MG Oral Tablet
NAMESTallman SynonymmedroxyPROGESTERone acetate 2.5 MG Oral Tablet [Provera]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon