FDA.reportPublic FDA data

estrogens, conjugated (USP) 0.3 MG Oral Tablet

RxCUI
197660
RxNorm name
estrogens, conjugated (USP) 0.3 MG Oral Tablet
Display name
Estrogens, conjugated (USP) (Oral Pill)
Full name
estrogens, conjugated (USP) 0.3 MG Oral Tablet
Term type
SCD
Status
Active
Strength
0.3 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-11-06 11:39:39

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
042005
Active start
042005
Multiple ingredient
NO
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)

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

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

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRestrogens, conjugated (USP) 0.3 MG Oral Tablet1NAMES
RxNorm Nameestrogens, conjugated (USP) 0.3 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI1976601CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
50742-387-0150742-387estrogens, conjugated estrogens, conjugatedIngenus Pharmaceuticals, LLCANDA214025
50742-387-1050742-387estrogens, conjugated estrogens, conjugatedIngenus Pharmaceuticals, LLCANDA214025
66993-295-0266993-295Conjugated Estrogens estrogens, conjugatedPrasco LaboratoriesNDA004782

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA21402550742-387estrogens, conjugated estrogens, conjugatedANDAIngenus Pharmaceuticals, LLC
NDA00478266993-295Conjugated Estrogens estrogens, conjugatedNDA AUTHORIZED GENERICPrasco Laboratories

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 100 matching rows.

NDC11, Source, Active table
NDC11SourceActive
50742038701rxnav_ndcsyes
50742038710rxnav_ndcsyes
66993029502rxnav_ndcsyes
00008086806rxnav_historical
00008086807rxnav_historical
00008086881rxnav_historical
00008086891rxnav_historical
00008110051rxnav_historical
00008110081rxnav_historical
00008110091rxnav_historical
00046086806rxnav_historical
00046086807rxnav_historical
00046086881rxnav_historical
00046086891rxnav_historical
00046110081rxnav_historical
00046110091rxnav_historical
00102249001rxnav_historical
00157088401rxnav_historical
00172363660rxnav_historical
00179117301rxnav_historical
00179117370rxnav_historical
00179117371rxnav_historical
00179117372rxnav_historical
00179117390rxnav_historical
00182173901rxnav_historical
00228216910rxnav_historical
00247122630rxnav_historical
00349850201rxnav_historical
00349850210rxnav_historical
00364083601rxnav_historical
00406110051rxnav_historical
00406110081rxnav_historical
00406110091rxnav_historical
00536351701rxnav_historical
00677060701rxnav_historical
00719123910rxnav_historical
00781113201rxnav_historical
00839707806rxnav_historical
00894703501rxnav_historical
00894703502rxnav_historical
00894703503rxnav_historical
00894703504rxnav_historical
00904204060rxnav_historical
26053013301rxnav_historical
40039031001rxnav_historical
47202251901rxnav_historical
48817688101rxnav_historical
51129362301rxnav_historical
51129362302rxnav_historical
51285023502rxnav_historical
51285023505rxnav_historical
51432010703rxnav_historical
51813021899rxnav_historical
52985009101rxnav_historical
53146000399rxnav_historical
53489022401rxnav_historical
53978344009rxnav_historical
54569081101rxnav_historical
54569081150rxnav_historical
54569851700rxnav_historical
54569851701rxnav_historical
54868270200rxnav_historical
54868270201rxnav_historical
54868270202rxnav_historical
54868270203rxnav_historical
54868270204rxnav_historical
55289012330rxnav_historical
57866668001rxnav_historical
57866668002rxnav_historical
58016074400rxnav_historical
58016074410rxnav_historical
58016074412rxnav_historical
58016074414rxnav_historical
58016074415rxnav_historical
58016074420rxnav_historical
58016074430rxnav_historical
58056015910rxnav_historical
58056015981rxnav_historical
58087001275rxnav_historical
60491051430rxnav_historical
60491051434rxnav_historical
60491051460rxnav_historical
61392098731rxnav_historical
61392098739rxnav_historical
62584086890rxnav_historical
63874015801rxnav_historical
63874015810rxnav_historical
63874015814rxnav_historical
63874015815rxnav_historical
63874015820rxnav_historical
63874015830rxnav_historical
65084022510rxnav_historical
66267024610rxnav_historical
66267024615rxnav_historical
66267024620rxnav_historical
66267024630rxnav_historical
66267024640rxnav_historical
67228018503rxnav_historical
67228018506rxnav_historical
68258908701rxnav_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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
estrogens, conjugatedESTROGENS, CONJUGATEDIngenus Pharmaceuticals, LLCb17eca23-f387-4243-a76a-bcf6b88aeef92026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 50742-387-01
ndc (package): 50742-387-10
ndc (product): 50742-387
ndc11 (package): 50742038710
ndc11 (package): 50742038701
rxcui: 197660
PremarinESTROGENS, CONJUGATEDWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.258e1602-a3cf-4ccc-ca80-73dbbfb812ff2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
ndc11 (package): 00046110091
ndc11 (package): 00046110081
rxcui: 197660
Conjugated EstrogensESTROGENS, CONJUGATEDPrasco Laboratoriesce793f9e-0c20-43e6-9dc0-064e5c82e2432026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 66993-295-02
ndc (product): 66993-295
ndc11 (package): 66993029502
rxcui: 197660
PREMARINESTROGENS, CONJUGATEDA-S Medication Solutions2b4dbb7c-4e6d-47c9-b940-fef91f1f4a052024-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197660

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 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
2b4dbb7c-4e6d-47c9-b940-fef91f1f4a05estrogens, conjugated 0.3 MG Oral Tablet [PSN] · estrogens, conjugated (USP) 0.3 MG Oral Tablet [SCD]29These highlights do not include all the information needed to use PREMARIN safely and effectively. See full prescribing information for PREMARIN. PREMARIN® (conjugated estrogens) Tablets, USP for oral use Initial U.S. Approval: 194220240204
b32fcb1b-fee4-44b8-a91c-10dfdd3f84eaestrogens, conjugated 0.3 MG Oral Tablet [PSN] · estrogens, conjugated (USP) 0.3 MG Oral Tablet [SCD]2320140508
ce793f9e-0c20-43e6-9dc0-064e5c82e243estrogens, conjugated 0.3 MG Oral Tablet [PSN] · estrogens, conjugated (USP) 0.3 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use CONJUGATED ESTROGENS TABLETS safely and effectively. See full prescribing information for CONJUGATED ESTROGENS TABLETS. Conjugated Estrogens Tablets, for oral use Initial U.S. Approval: 194220260227
b17eca23-f387-4243-a76a-bcf6b88aeef9estrogens, conjugated 0.3 MG Oral Tablet [PSN] · estrogens, conjugated (USP) 0.3 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use CONJUGATED ESTROGENS TABLETS safely and effectively. See full prescribing information for CONJUGATED ESTROGENS TABLETS. CONJUGATED ESTROGENS tablets，for oral use Initial U.S. Approval: 194220251016
751b6213-92d8-40f8-a2d5-83e8dad086ddestrogens, conjugated 0.3 MG Oral Tablet [PSN] · estrogens, conjugated (USP) 0.3 MG Oral Tablet [SCD]21PREMARIN ® (conjugated estrogens tablets, USP)20120718

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
b17eca23-f387-4243-a76a-bcf6b88aeef9These highlights do not include all the information needed to use CONJUGATED ESTROGENS TABLETS safely and effectively. See full prescribing information for CONJUGATED ESTROGENS TABLETS. CONJUGATED ESTROGENS tablets，for oral use Initial U.S. Approval: 1942Ingenus Pharmaceuticals, LLC | Novast Laboratories, Ltd.20260825
258e1602-a3cf-4ccc-ca80-73dbbfb812ffThese highlights do not include all the information needed to use PREMARIN safely and effectively. See full prescribing information for PREMARIN. PREMARIN® (conjugated estrogens) tablets, for oral use Initial U.S. Approval: 1942Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Pfizer Italia S.r.l. | Pfizer Canada ULC | Pfizer Ireland Pharmaceuticals Unlimited Company20260604
ce793f9e-0c20-43e6-9dc0-064e5c82e243These highlights do not include all the information needed to use CONJUGATED ESTROGENS TABLETS safely and effectively. See full prescribing information for CONJUGATED ESTROGENS TABLETS. Conjugated Estrogens Tablets, for oral use Initial U.S. Approval: 1942Prasco Laboratories | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Pfizer Italia S.r.l. | Pfizer Canada ULC | Pfizer Ireland Pharmaceuticals Unlimited Company20260227
258e1602-a3cf-4ccc-ca80-73dbbfb812ffThese highlights do not include all the information needed to use PREMARIN safely and effectively. See full prescribing information for PREMARIN. PREMARIN® (conjugated estrogens) tablets, for oral use Initial U.S. Approval: 1942Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Pfizer Italia S.r.l. | Pfizer Canada ULC | Pfizer Ireland Pharmaceuticals Unlimited Company20260220
b17eca23-f387-4243-a76a-bcf6b88aeef9These highlights do not include all the information needed to use CONJUGATED ESTROGENS TABLETS safely and effectively. See full prescribing information for CONJUGATED ESTROGENS TABLETS. CONJUGATED ESTROGENS tablets，for oral use Initial U.S. Approval: 1942Ingenus Pharmaceuticals, LLC | Novast Laboratories, Ltd.20251016
b32fcb1b-fee4-44b8-a91c-10dfdd3f84eaPhysicians Total Care, Inc.20140508
07343735-2a48-4eb9-ab7f-16966356238aNational Council for Prescription Drug Programs20120724
0bdf0512-86bf-4352-b349-8bb3bd12dbf3National Council for Prescription Drug Programs20120724
37db3830-c074-4210-a346-bedf36b5cb85National Council for Prescription Drug Programs20120724
a628176f-7fb3-489d-8c25-c3f39a7a5b8fNational Council for Prescription Drug Programs20120724
cce41567-13cf-4851-9e99-74fd14d1d08cNational Council for Prescription Drug Programs20120724
e5812917-a113-4837-86f6-23c56a71dadbNational Council for Prescription Drug Programs20120724
ee8b5e40-1685-4dfe-bc3d-091e86b64968National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCG03CANatural and semisynthetic estrogens, plainATC1-4estrogens, conjugated (USP)
FDASPLD004966Estrogens, Conjugated (USP)CHEMhas_chemical_structureestrogens, conjugated (USP)
FDASPLN0000175825EstrogenEPChas_epcestrogens, conjugated (USP)
FDASPLN0000000100Estrogen Receptor AgonistsMOAhas_moaestrogens, conjugated (USP)
MEDRTD004966Estrogens, Conjugated (USP)CHEMhas_ingredientestrogens, conjugated (USP)
MEDRTD020152Antithrombin III DeficiencyDISEASEci_withestrogens, conjugated (USP)
MEDRTD001943Breast NeoplasmsDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD001943Breast NeoplasmsDISEASEci_withestrogens, conjugated (USP)
MEDRTD004342Drug HypersensitivityDISEASEci_withestrogens, conjugated (USP)
MEDRTD006470HemorrhageDISEASEci_withestrogens, conjugated (USP)
MEDRTD019584Hot FlashesDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD007006HypogonadismDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD008107Liver DiseasesDISEASEci_withestrogens, conjugated (USP)
MEDRTD008594Menopause, PrematureDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD008595MenorrhagiaDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD009376Neoplasms, Hormone-DependentDISEASEci_withestrogens, conjugated (USP)
MEDRTD015663Osteoporosis, PostmenopausalDISEASEmay_preventestrogens, conjugated (USP)
MEDRTD011247PregnancyDISEASEci_withestrogens, conjugated (USP)
MEDRTD016649Primary Ovarian InsufficiencyDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD011471Prostatic NeoplasmsDISEASEmay_treatestrogens, conjugated (USP)
MEDRTD011655Pulmonary EmbolismDISEASEci_withestrogens, conjugated (USP)
MEDRTD013923ThromboembolismDISEASEci_withestrogens, conjugated (USP)
MEDRTD013924ThrombophlebitisDISEASEci_withestrogens, conjugated (USP)
MEDRTD020246Venous ThrombosisDISEASEci_withestrogens, conjugated (USP)
MEDRTN0000000100Estrogen Receptor AgonistsMOAhas_moaestrogens, conjugated (USP)
MEDRTN0000008311Bone Formation StimulationPEhas_peestrogens, conjugated (USP)
MEDRTN0000009051Gonadotropin Releasing Hormone AlterationPEhas_peestrogens, conjugated (USP)
MEDRTN0000009065Hematologic Activity AlterationPEci_peestrogens, conjugated (USP)
MEDRTN0000009805Pituitary Gland Activity AlterationPEhas_peestrogens, conjugated (USP)
MEDRTN0000009902Vaginal Function AlterationPEhas_peestrogens, conjugated (USP)
MEDRTN0000000026Hepatic MetabolismPKhas_pkestrogens, conjugated (USP)
MEDRTN0000000042Renal ExcretionPKhas_pkestrogens, conjugated (USP)

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.3 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA214025
CODESSNOMEDCT409118006
CODESVUID4004641
NAMESPrescribable Synonymestrogens, conjugated 0.3 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File