FDA.reportPublic FDA data

medroxyprogesterone acetate 10 MG Oral Tablet [Provera]

RxCUI
1000124
RxNorm name
medroxyprogesterone acetate 10 MG Oral Tablet [Provera]
Display name
PROVERA (Oral Pill)
Full name
medroxyprogesterone acetate 10 MG Oral Tablet [Provera]
Term type
SBD
Status
Active
Strength
10 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-21 07:26:21

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 acetate10 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 10 MG Oral Tablet1NAMES
RxNorm Namemedroxyprogesterone acetate 10 MG Oral Tablet [Provera]1NAMES
RxNorm SynonymProvera 10 MG Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDa586be28-96af-4fed-a13f-9b94fd4c74051CODES
RxCUI10001241CODES
MMSL_CODEBD18471CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0009-0051-010009-0051Provera medroxyprogesterone acetatePharmacia & Upjohn Company LLCNDA011839

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0118390009-0051Provera medroxyprogesterone acetateNDAPharmacia & Upjohn Company LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 28 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00009005002rxnav_ndcsyes
00009005101rxnav_ndcsyes
55289003410rxnav_ndcsyes
00009005009rxnav_historical
00009005011rxnav_historical
00009005027rxnav_historical
00009005102rxnav_historical
00855331150rxnav_historical
11822526901rxnav_historical
12634074600rxnav_historical
51129900501rxnav_historical
53978338909rxnav_historical
54569081600rxnav_historical
54569852400rxnav_historical
54569852401rxnav_historical
54868029000rxnav_historical
54868029002rxnav_historical
54868029003rxnav_historical
54868029004rxnav_historical
58056028010rxnav_historical
60491054601rxnav_historical
60491054630rxnav_historical
60491054634rxnav_historical
65084020010rxnav_historical_indirect
65427005002rxnav_historical
65427005009rxnav_historical
65427005011rxnav_historical
66267085110rxnav_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): 0009-0051-01
ndc (product): 0009-0051
ndc11 (package): 00009005101
rxcui: 1000124

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 10 MG Oral Tablet [PSN] · medroxyprogesterone acetate 10 MG Oral Tablet [Provera] [SBD] · Provera 10 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
3f6529dd-3172-442c-922c-3337ad4ca037National Council for Prescription Drug Programs20120724
648174bf-c531-47dd-870d-6f0213794ea0National Council for Prescription Drug Programs20120724

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_STRENGTH10 MG (expressed as medroxyprogesterone acetate)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA011839
NAMESPrescribable SynonymProvera 10 MG Oral Tablet
NAMESTallman SynonymmedroxyPROGESTERone acetate 10 MG Oral Tablet [Provera]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon