FDA.reportPublic FDA data

{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day]

RxCUI
1000499
RxNorm name
{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day]
Display name
PREMPRO 0.625/2.5 28 DAY (Pack)
Full name
{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day]
Term type
BPCK
Status
Active
Strength
mixed
Dose form
Pack
Route
Pack
Updated
2026-10-21 07:27:58

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092010
Active start
092010
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
estrogens, conjugated (USP)0.625 MG / 1 EACHestrogens, conjugated (USP)estrogens, conjugated (USP)
medroxyprogesterone acetate2.5 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_STRPrempro 0.625/2.5 28 Day Pack1NAMES
RxNorm Name{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day]1NAMES
RxNorm SynonymPrempro 0.625/2.5 28 Day Pack1NAMES
TTYBPCK1ATTRIBUTES
SPL_SET_IDfd0c0836-5d23-2183-da81-9dc7f42870521CODES
RxCUI10004991CODES
MMSL_CODEBD36711CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0046-1107-110046-1107Prempro conjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDA020527

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0205270046-1107Prempro conjugated estrogens and medroxyprogesterone acetateNDAWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 23 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00046110711rxnav_ndcsyes
50090057300rxnav_ndcsyes
00046087501rxnav_historical
00046087502rxnav_historical
00046087503rxnav_historical_indirect
00046087504rxnav_historical_indirect
00046087505rxnav_historical
00046087506rxnav_historical
00046087511rxnav_historical
00046087551rxnav_historical_indirect
00046257201rxnav_historical_indirect
00046257202rxnav_historical_indirect
00247170201rxnav_historical
00247170228rxnav_historical
35356027728rxnav_historical
54569436500rxnav_historical
54569461800rxnav_historical
54868379900rxnav_historical
54868554000rxnav_historical_indirect
55045256103rxnav_historical
58016407401rxnav_historical
60491090401rxnav_historical
68258598002rxnav_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
PremproCONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.fd0c0836-5d23-2183-da81-9dc7f42870522026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0046-1107-11
ndc (product): 0046-1107
ndc11 (package): 00046110711
rxcui: 1000499

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 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
fd0c0836-5d23-2183-da81-9dc7f4287052{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day] [BPCK] · PREMPRO 0.625/2.5 28 Day Pack [PSN] · Prempro 0.625/2.5 28 Day Pack [SY]339These 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
3aff3442-641c-4639-8273-cf0347d8e4c8{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day] [BPCK] · PREMPRO 0.625/2.5 28 Day Pack [PSN] · Prempro 0.625/2.5 28 Day Pack [SY]321These 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: 199520210205
198d547d-c985-46bc-a66f-e3182a294cb5{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day] [BPCK] · PREMPRO 0.625/2.5 28 Day Pack [PSN] · Prempro 0.625/2.5 28 Day Pack [SY]33These 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) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day] [BPCK] · PREMPRO 0.625/2.5 28 Day Pack [PSN] · Prempro 0.625/2.5 28 Day Pack [SY]33These 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
fd0c0836-5d23-2183-da81-9dc7f4287052These 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: 1995Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Pfizer Italia S.r.l. | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Canada ULC20260428
fd0c0836-5d23-2183-da81-9dc7f4287052These 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: 1995Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Pfizer Italia S.r.l. | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Inc | Pfizer Canada ULC20251104
fd0c0836-5d23-2183-da81-9dc7f4287052These 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: 1995Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Pfizer Italia S.r.l. | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Inc | Pfizer Canada ULC20250506
3aff3442-641c-4639-8273-cf0347d8e4c8These 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: 1995A-S Medication Solutions20210205
198d547d-c985-46bc-a66f-e3182a294cb5These 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: 1995Dispensing Solutions, Inc. | PSS World Medical, Inc.20130227
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
105ea21e-b7e3-4b30-a2fd-e0876f27dc7aNational Council for Prescription Drug Programs20120724
9dec9f70-ad23-46c8-8223-c567f08f130eNational Council for Prescription Drug Programs20120724
c7558707-adc4-4df0-939e-1e548071994eNational 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
ATTRIBUTESSCHEDULE0
CODESNDANDA020527
CODESVUID4013248
NAMESPrescribable SynonymPREMPRO 0.625/2.5 28 Day Pack
NAMESTallman Synonym{28 (estrogens, conjugated (USP) 0.625 MG / medroxyPROGESTERone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceVeterans Health Administration National Drug File