FDA.reportPublic FDA data

{14 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 5 MG Oral Tablet) / 14 (estrogens, conjugated (USP) 0.625 MG Oral Tablet) } Pack [Premphase 28 Day]

RxCUI
1000487
RxNorm name
{14 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 5 MG Oral Tablet) / 14 (estrogens, conjugated (USP) 0.625 MG Oral Tablet) } Pack [Premphase 28 Day]
Display name
PREMPHASE 28 DAY (Pack)
Full name
{14 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 5 MG Oral Tablet) / 14 (estrogens, conjugated (USP) 0.625 MG Oral Tablet) } Pack [Premphase 28 Day]
Term type
BPCK
Status
Active
Strength
mixed
Dose form
Pack
Route
Pack
Updated
2026-10-21 07:27:48

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 acetate5 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_STRPremphase 28 Day Pack1NAMES
RxNorm Name{14 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 5 MG Oral Tablet) / 14 (estrogens, conjugated (USP) 0.625 MG Oral Tablet) } Pack [Premphase 28 Day]1NAMES
RxNorm SynonymPremphase 28 Day Pack1NAMES
TTYBPCK1ATTRIBUTES
SPL_SET_IDfd0c0836-5d23-2183-da81-9dc7f42870521CODES
RxCUI10004871CODES
MMSL_CODEBD81471CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0046-2575-120046-2575Premphase conjugated estrogens and medroxyprogesterone acetateWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDA020527

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0205270046-2575Premphase 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 · 16 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00046257512rxnav_ndcsyes
00008257302rxnav_historical_indirect
00008257305rxnav_historical_indirect
00008257306rxnav_historical_indirect
00008257308rxnav_historical_indirect
00046257301rxnav_historical
00046257302rxnav_historical
00046257305rxnav_historical
00046257306rxnav_historical
00046257308rxnav_historical_indirect
00046257901rxnav_historical_indirect
00046257911rxnav_historical
00247170328rxnav_historical
54569467300rxnav_historical
54868380000rxnav_historical
60491090301rxnav_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): 0046-2575-12
ndc (product): 0046-2575
ndc11 (package): 00046257512
rxcui: 1000487

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
fd0c0836-5d23-2183-da81-9dc7f4287052{14 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 5 MG Oral Tablet) / 14 (estrogens, conjugated (USP) 0.625 MG Oral Tablet) } Pack [Premphase 28 Day] [BPCK] · Premphase 28 Day Pack [PSN] · Premphase 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
701acf2c-fffe-451a-9b94-82d825e5a47c{14 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 5 MG Oral Tablet) / 14 (estrogens, conjugated (USP) 0.625 MG Oral Tablet) } Pack [Premphase 28 Day] [BPCK] · Premphase 28 Day Pack [PSN] · Premphase 28 Day Pack [SY]32These 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: 199520121126

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
d7d23ed9-8f98-4c51-8c9c-10a0e7358ee3National Council for Prescription Drug Programs20130401
5de27d2e-3ffb-4518-ac1a-6a71d44a0d9dNational Council for Prescription Drug Programs20130213
701acf2c-fffe-451a-9b94-82d825e5a47cThese 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.20121126
2121b86f-02f4-42d8-bce0-81ff8d58dd3aNational 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
CODESVUID4012711
NAMESPrescribable SynonymPremphase 28 Day Pack
NAMESTallman Synonym{14 (estrogens, conjugated (USP) 0.625 MG / medroxyPROGESTERone acetate 5 MG Oral Tablet) / 14 (estrogens, conjugated (USP) 0.625 MG Oral Tablet) } Pack [Premphase 28 Day]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceVeterans Health Administration National Drug File