FDA.reportPublic FDA data

{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } Pack

RxCUI
1000490
RxNorm name
{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } Pack
Display name
Estrogens, conjugated (USP)/medroxyPROGESTERone (Pack)
Full name
{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } Pack
Term type
GPCK
Status
Active
Strength
mixed
Dose form
Pack
Route
Pack
Updated
2026-10-21 07:27:50

RxNorm Status History#

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

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
estrogens, conjugated (USP)0.3 MG / 1 EACHestrogens, conjugated (USP)estrogens, conjugated (USP)
medroxyprogesterone acetate1.5 MG / 1 EACHmedroxyprogesteronemedroxyprogesterone acetate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Pack746839

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
estrogens, conjugated (USP)4099
medroxyprogesterone6691

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR{28 (estrogens, conjugated (USP) 0.3 MG / medroxyPROGESTERone acetate 1.5 MG Oral Tablet) } Pack1NAMES
RxNorm Name{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } Pack1NAMES
TTYGPCK1ATTRIBUTES
RxCUI10004901CODES

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 7 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00046093802rxnav_historical_indirect
00046093808rxnav_historical_indirect
00046093809rxnav_historical_indirect
00046093810rxnav_historical_indirect
00046093811rxnav_historical_indirect
00046093851rxnav_historical_indirect
54868504700rxnav_historical_indirect

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
PremproCONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.fd0c0836-5d23-2183-da81-9dc7f42870522026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000490

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 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
fd0c0836-5d23-2183-da81-9dc7f4287052{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } Pack [GPCK] · Estrogens Conj-Medroxyprogest Ac 0.3-1.5 MG (28) Oral Tablet 28 Day Pack [PSN]239These highlights do not include all the information needed to use PREMPRO/PREMPHASE safely and effectively. See full prescribing information for PREMPRO/PREMPHASE. PREMPRO ® (conjugated estrogens/medroxyprogesterone acetate tablets) PREMPHASE ® (conjugated estrogens plus medroxyprogesterone acetate tablets) Initial U.S. Approval: 199520260428
198d547d-c985-46bc-a66f-e3182a294cb5{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } Pack [GPCK] · Estrogens Conj-Medroxyprogest Ac 0.3-1.5 MG (28) Oral Tablet 28 Day Pack [PSN]23These highlights do not include all the information needed to use PREMPRO/PREMPHASE safely and effectively. See full prescribing information for PREMPRO/PREMPHASE. PREMPRO ® (conjugated estrogens/medroxyprogesterone acetate tablets) PREMPHASE ® (conjugated estrogens plus medroxyprogesterone acetate tablets) Initial U.S. Approval: 199520130227
36ec4df9-298d-4b15-9386-7848d217a46c{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } Pack [GPCK] · Estrogens Conj-Medroxyprogest Ac 0.3-1.5 MG (28) Oral Tablet 28 Day Pack [PSN]23These highlights do not include all the information needed to use PREMPRO/PREMPHASE safely and effectively. See full prescribing information for PREMPRO/PREMPHASE. PREMPRO ® (conjugated estrogens/medroxyprogesterone acetate tablets) PREMPHASE ® (conjugated estrogens plus medroxyprogesterone acetate tablets) Initial U.S. Approval: 199520121101

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
36ec4df9-298d-4b15-9386-7848d217a46cThese highlights do not include all the information needed to use PREMPRO/PREMPHASE safely and effectively. See full prescribing information for PREMPRO/PREMPHASE. PREMPRO ® (conjugated estrogens/medroxyprogesterone acetate tablets) PREMPHASE ® (conjugated estrogens plus medroxyprogesterone acetate tablets) Initial U.S. Approval: 1995Physicians Total Care, Inc.20121101
69f25b5b-bcb7-4ffa-8ca6-e9341d19e9c5National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCG03CANatural and semisynthetic estrogens, plainATC1-4estrogens, conjugated (USP)
ATCG03DAPregnen (4) derivativesATC1-4medroxyprogesterone
ATCL02ABProgestogensATC1-4medroxyprogesterone
ATCG03ACProgestogensATC1-4medroxyprogesterone
FDASPLD004966Estrogens, Conjugated (USP)CHEMhas_chemical_structureestrogens, conjugated (USP)
FDASPLD045167Progesterone CongenersCHEMhas_chemical_structuremedroxyprogesterone
FDASPLN0000175825EstrogenEPChas_epcestrogens, conjugated (USP)
FDASPLN0000175602ProgestinEPChas_epcmedroxyprogesterone
FDASPLN0000000100Estrogen Receptor AgonistsMOAhas_moaestrogens, conjugated (USP)
MEDRTD004966Estrogens, Conjugated (USP)CHEMhas_ingredientestrogens, conjugated (USP)
MEDRTD008525MedroxyprogesteroneCHEMhas_ingredientmedroxyprogesterone
MEDRTD017258Medroxyprogesterone AcetateCHEMhas_ingredientmedroxyprogesterone acetate
MEDRTD000568AmenorrheaDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD000568AmenorrheaDISEASEmay_treatmedroxyprogesterone
MEDRTD020152Antithrombin III DeficiencyDISEASEci_withestrogens, conjugated (USP)
MEDRTD001943Breast NeoplasmsDISEASEci_withmedroxyprogesterone acetate
MEDRTD001943Breast NeoplasmsDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD001943Breast NeoplasmsDISEASEci_withestrogens, conjugated (USP)
MEDRTD001943Breast NeoplasmsDISEASEci_withmedroxyprogesterone
MEDRTD001943Breast NeoplasmsDISEASEmay_treatmedroxyprogesterone
MEDRTD001943Breast NeoplasmsDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD002292Carcinoma, Renal CellDISEASEmay_treatmedroxyprogesterone
MEDRTD002292Carcinoma, Renal CellDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD002543Cerebral HemorrhageDISEASEci_withmedroxyprogesterone
MEDRTD002543Cerebral HemorrhageDISEASEci_withmedroxyprogesterone acetate
MEDRTD004342Drug HypersensitivityDISEASEci_withestrogens, conjugated (USP)
MEDRTD004342Drug HypersensitivityDISEASEci_withmedroxyprogesterone acetate
MEDRTD004342Drug HypersensitivityDISEASEci_withmedroxyprogesterone
MEDRTD004714Endometrial HyperplasiaDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD004714Endometrial HyperplasiaDISEASEmay_treatmedroxyprogesterone
MEDRTD016889Endometrial NeoplasmsDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD016889Endometrial NeoplasmsDISEASEmay_treatmedroxyprogesterone
MEDRTD006470HemorrhageDISEASEci_withmedroxyprogesterone acetate
MEDRTD006470HemorrhageDISEASEci_withmedroxyprogesterone
MEDRTD006470HemorrhageDISEASEci_withestrogens, conjugated (USP)
MEDRTD019584Hot FlashesDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD007006HypogonadismDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD007040HypoventilationDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD007040HypoventilationDISEASEmay_treatmedroxyprogesterone
MEDRTD008107Liver DiseasesDISEASEci_withmedroxyprogesterone acetate
MEDRTD008107Liver DiseasesDISEASEci_withmedroxyprogesterone
MEDRTD008107Liver DiseasesDISEASEci_withestrogens, conjugated (USP)
MEDRTD008594Menopause, PrematureDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD008595MenorrhagiaDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD009376Neoplasms, Hormone-DependentDISEASEci_withestrogens, conjugated (USP)
MEDRTD009376Neoplasms, Hormone-DependentDISEASEci_withmedroxyprogesterone acetate
MEDRTD009376Neoplasms, Hormone-DependentDISEASEci_withmedroxyprogesterone
MEDRTD015663Osteoporosis, PostmenopausalDISEASEmay_preventestrogens, conjugated (USP)
MEDRTD011247PregnancyDISEASEmay_preventmedroxyprogesterone acetate
MEDRTD011247PregnancyDISEASEci_withestrogens, conjugated (USP)
MEDRTD011247PregnancyDISEASEci_withmedroxyprogesterone acetate
MEDRTD011247PregnancyDISEASEci_withmedroxyprogesterone
MEDRTD011247PregnancyDISEASEmay_preventmedroxyprogesterone
MEDRTD016649Primary Ovarian InsufficiencyDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD011471Prostatic NeoplasmsDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD011655Pulmonary EmbolismDISEASEci_withmedroxyprogesterone
MEDRTD011655Pulmonary EmbolismDISEASEci_withmedroxyprogesterone acetate
MEDRTD011655Pulmonary EmbolismDISEASEci_withestrogens, conjugated (USP)
MEDRTD013923ThromboembolismDISEASEci_withestrogens, conjugated (USP)
MEDRTD013924ThrombophlebitisDISEASEci_withmedroxyprogesterone acetate
MEDRTD013924ThrombophlebitisDISEASEci_withmedroxyprogesterone
MEDRTD013924ThrombophlebitisDISEASEci_withestrogens, conjugated (USP)
MEDRTD014592Uterine HemorrhageDISEASEmay_treatmedroxyprogesterone
MEDRTD014592Uterine HemorrhageDISEASEci_withmedroxyprogesterone acetate
MEDRTD014592Uterine HemorrhageDISEASEmay_treatmedroxyprogesterone acetate
MEDRTD014592Uterine HemorrhageDISEASEci_withmedroxyprogesterone
MEDRTD014623Vaginal DiseasesDISEASEci_withmedroxyprogesterone acetate
MEDRTD014623Vaginal DiseasesDISEASEci_withmedroxyprogesterone
MEDRTD020246Venous ThrombosisDISEASEci_withmedroxyprogesterone
MEDRTD020246Venous ThrombosisDISEASEci_withmedroxyprogesterone acetate
MEDRTD020246Venous ThrombosisDISEASEci_withestrogens, conjugated (USP)
MEDRTN0000000100Estrogen Receptor AgonistsMOAhas_moaestrogens, conjugated (USP)
MEDRTN0000000185Progestational Hormone Receptor AgonistsMOAhas_moamedroxyprogesterone acetate
MEDRTN0000000185Progestational Hormone Receptor AgonistsMOAhas_moamedroxyprogesterone
MEDRTN0000008311Bone Formation StimulationPEhas_peestrogens, conjugated (USP)
MEDRTN0000008630Decreased Follicle Stimulating Hormone SecretionPEhas_pemedroxyprogesterone acetate
MEDRTN0000008630Decreased Follicle Stimulating Hormone SecretionPEhas_pemedroxyprogesterone
MEDRTN0000008632Decreased Growth Hormone SecretionPEhas_pemedroxyprogesterone
MEDRTN0000008632Decreased Growth Hormone SecretionPEhas_pemedroxyprogesterone acetate
MEDRTN0000009051Gonadotropin Releasing Hormone AlterationPEhas_pemedroxyprogesterone acetate
MEDRTN0000009051Gonadotropin Releasing Hormone AlterationPEhas_peestrogens, conjugated (USP)
MEDRTN0000009051Gonadotropin Releasing Hormone AlterationPEhas_pemedroxyprogesterone
MEDRTN0000009065Hematologic Activity AlterationPEci_peestrogens, conjugated (USP)
MEDRTN0000009715Inhibit Ovarian Follicular PhasePEhas_pemedroxyprogesterone acetate
MEDRTN0000009715Inhibit Ovarian Follicular PhasePEhas_pemedroxyprogesterone
MEDRTN0000009717Inhibit OvulationPEhas_pemedroxyprogesterone
MEDRTN0000009717Inhibit OvulationPEhas_pemedroxyprogesterone acetate
MEDRTN0000009805Pituitary Gland Activity AlterationPEhas_peestrogens, conjugated (USP)
MEDRTN0000009857Stimulate Breast Glandular DevelopmentPEhas_pemedroxyprogesterone acetate
MEDRTN0000009857Stimulate Breast Glandular DevelopmentPEhas_pemedroxyprogesterone
MEDRTN0000009902Vaginal Function AlterationPEhas_peestrogens, conjugated (USP)
MEDRTN0000000043Hepatic ExcretionPKhas_pkmedroxyprogesterone acetate
MEDRTN0000000043Hepatic ExcretionPKhas_pkmedroxyprogesterone
MEDRTN0000000026Hepatic MetabolismPKhas_pkmedroxyprogesterone
MEDRTN0000000026Hepatic MetabolismPKhas_pkmedroxyprogesterone acetate
MEDRTN0000000026Hepatic MetabolismPKhas_pkestrogens, conjugated (USP)
MEDRTN0000000042Renal ExcretionPKhas_pkmedroxyprogesterone acetate
MEDRTN0000000042Renal ExcretionPKhas_pkestrogens, conjugated (USP)
MEDRTN0000000042Renal ExcretionPKhas_pkmedroxyprogesterone

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
NAMESPrescribable SynonymEstrogens Conj-Medroxyprogest Ac 0.3-1.5 MG (28) Oral Tablet 28 Day Pack
NAMESTallman Synonym{28 (estrogens, conjugated (USP) 0.3 MG / medroxyPROGESTERone acetate 1.5 MG Oral Tablet) } Pack
SOURCESSourceMicromedex RED BOOK