FDA.reportPublic FDA data

estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin]

RxCUI
150840
RxNorm name
estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin]
Display name
PREMARIN (Oral Pill)
Full name
estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin]
Term type
SBD
Status
Active
Strength
0.625 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-22 06:59:06

RxNorm Status History#

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

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_STRPremarin 0.625 MG Oral Tablet1NAMES
RxNorm Nameestrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin]1NAMES
RxNorm SynonymPremarin 0.625 MG Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
4 linked values
4CODES
RxCUI1508401CODES
MMSL_CODEBD331CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0046-1102-520046-1102Premarin estrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDA004782
0046-1102-810046-1102Premarin estrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDA004782
0046-1102-910046-1102Premarin estrogens, conjugatedWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDA004782
50090-0167-050090-0167Premarin estrogens, conjugatedA-S Medication SolutionsNDA004782
50090-0167-550090-0167Premarin estrogens, conjugatedA-S Medication SolutionsNDA004782

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0047820046-1102Premarin estrogens, conjugatedNDAWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 2 of 2 · 179 matching rows.

NDC11, Source, Active table
NDC11SourceActive
58016094828rxnav_historical
58016094830rxnav_historical
58016094832rxnav_historical
58016094835rxnav_historical
58016094836rxnav_historical
58016094840rxnav_historical
58016094842rxnav_historical
58016094844rxnav_historical
58016094845rxnav_historical
58016094848rxnav_historical
58016094850rxnav_historical
58016094856rxnav_historical
58016094860rxnav_historical
58016094870rxnav_historical
58016094872rxnav_historical
58016094875rxnav_historical
58016094876rxnav_historical
58016094880rxnav_historical
58016094884rxnav_historical
58016094890rxnav_historical
58016094892rxnav_historical
58016094896rxnav_historical
58016094897rxnav_historical
58016094899rxnav_historical
58056016010rxnav_historical
58056016075rxnav_historical
58056016081rxnav_historical
58056016091rxnav_historical
58295086701rxnav_historical
58864042228rxnav_historical
58864042230rxnav_historical
60491051520rxnav_historical
60491051530rxnav_historical
60491051534rxnav_historical
60491051550rxnav_historical
60491051590rxnav_historical
61392061925rxnav_historical
61392061930rxnav_historical
61392061931rxnav_historical
61392061951rxnav_historical
61392061960rxnav_historical
61392061990rxnav_historical
62584086700rxnav_historical
62584086790rxnav_historical
64579006500rxnav_historical
64579006501rxnav_historical
64725027003rxnav_historical
65084016910rxnav_historical
65084016912rxnav_historical
66116028530rxnav_historical
66336059930rxnav_historical
67228011803rxnav_historical
67228011806rxnav_historical
67801032603rxnav_historical
67801032635rxnav_historical
68115085830rxnav_historical
68788086700rxnav_historical
68788086703rxnav_historical
68788086706rxnav_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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PremarinESTROGENS, CONJUGATEDWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.258e1602-a3cf-4ccc-ca80-73dbbfb812ff2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0046-1102-52
ndc (package): 0046-1102-81
ndc (package): 0046-1102-91
ndc (product): 0046-1102
ndc11 (package): 00046110281
ndc11 (package): 00046110252
ndc11 (package): 00046110291
rxcui: 150840
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: 150840
PremarinESTROGENS, CONJUGATEDA-S Medication Solutionsa3b86b85-8923-42ae-aa31-a66a6e0903272025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 50090-0167-0
ndc (package): 50090-0167-5
ndc (product): 50090-0167
ndc11 (package): 50090016700
ndc11 (package): 50090016705
rxcui: 150840

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 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
fd0c0836-5d23-2183-da81-9dc7f4287052PREMARIN 0.625 MG Oral Tablet [PSN] · estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin] [SBD] · Premarin 0.625 MG Oral Tablet [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
a3b86b85-8923-42ae-aa31-a66a6e090327PREMARIN 0.625 MG Oral Tablet [PSN] · estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin] [SBD] · Premarin 0.625 MG Oral Tablet [SY]323These 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: 194220250402
b32fcb1b-fee4-44b8-a91c-10dfdd3f84eaPREMARIN 0.625 MG Oral Tablet [PSN] · estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin] [SBD] · Premarin 0.625 MG Oral Tablet [SY]3320140508
701acf2c-fffe-451a-9b94-82d825e5a47cPREMARIN 0.625 MG Oral Tablet [PSN] · estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin] [SBD] · Premarin 0.625 MG Oral Tablet [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
751b6213-92d8-40f8-a2d5-83e8dad086ddPREMARIN 0.625 MG Oral Tablet [PSN] · estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin] [SBD] · Premarin 0.625 MG Oral Tablet [SY]31PREMARIN ® (conjugated estrogens tablets, USP)20120718
1fcd61a8-1a67-4785-a51a-45fca6fbb32bPREMARIN 0.625 MG Oral Tablet [PSN] · estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin] [SBD] · Premarin 0.625 MG Oral Tablet [SY]31PREMARIN ® (conjugated estrogens tablets, USP)20100527

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
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
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
f3038133-8bb2-044e-e053-2995a90a6e7dThese highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989Northwind Health Company, LLC20260101
a3b86b85-8923-42ae-aa31-a66a6e090327These 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: 1942A-S Medication Solutions20250402
b32fcb1b-fee4-44b8-a91c-10dfdd3f84eaPhysicians Total Care, Inc.20140508
cbae4197-5e32-4de1-9816-9801c5d4e27bNational Council for Prescription Drug Programs20130213
7cfb461b-a1f5-4d71-9c9a-13c81fba43aeNational Council for Prescription Drug Programs20120724
fb689e79-4c4d-448d-97fc-585101b3edb6National Council for Prescription Drug Programs20120724
a7250132-3464-4fde-81b5-71ef325c6b9dNational Council for Prescription Drug Programs20120724
86dc37bd-52f0-4209-b23e-21513f04789cNational Council for Prescription Drug Programs20120724
8590f6a4-2b49-4b02-b399-7e728c3a9e66National Council for Prescription Drug Programs20120724
7d349a7f-705d-4415-a70f-9d22a703cd56National Council for Prescription Drug Programs20120724
09563355-fbd0-40bf-87fd-89b32b1aeef8National Council for Prescription Drug Programs20120724
6cc2d8d0-b2d3-49b1-b32f-b34b55af9b22National Council for Prescription Drug Programs20120724
684a65e2-4f84-478b-a628-1e7f973edcc3National Council for Prescription Drug Programs20120724
5e5aec38-4849-41e0-afe3-65cde0179c8cNational Council for Prescription Drug Programs20120724
50394188-e747-418d-bb0c-a756a944a9dbNational Council for Prescription Drug Programs20120724
751b6213-92d8-40f8-a2d5-83e8dad086ddPREMARIN ® (conjugated estrogens tablets, USP)Aphena Pharma Solutions - Tennessee, Inc.20120718
1fcd61a8-1a67-4785-a51a-45fca6fbb32bPREMARIN ® (conjugated estrogens tablets, USP)State of Florida DOH Central Pharmacy20100527

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_STRENGTH0.625 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA075796
CODESNDANDA004782
CODESNDANDA020527
NAMESPrescribable SynonymPREMARIN 0.625 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon