FDA.reportPublic FDA data

PREMARIN

Product NDC
50090-1853
11-digit product format
500901853
Labeler code
50090
Product ID
50090-1853_162fd047-bf5c-4c7d-9a60-01f0deb54290
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estrogens, conjugated
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA004782
Marketing category
NDA
Marketing start
2006-01-01
Substance
ESTROGENS, CONJUGATED
Active strength
.3 mg/1
Pharmacologic classes
Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PREMARIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTROGENS, CONJUGATED.3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIU5QR144QX
Rxcui197660, 208513

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d95be220-b30e-4165-a12d-f83825b0efb1Product name120160111
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
2e1ce74f-4938-37b4-e2b4-cfd7971b45eaProduct name120140508
d90784c3-64a2-2f23-9acd-d948d25bf235Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1853-32023-02-07C16284748780-1f386c649-9b13-0266-e053-dadaa90a7c1aThese 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: 1942
50090-1853-32023-01-30C16284748780-1f386c649-9b13-0266-e053-dadaa90a7c1aThese 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: 1942

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1853-3PREMARIN30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1853-3EA - Each50090-18539dc73c2b-a391-4979-996d-8a46305c78f412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1853PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20240206_2b4dbb7c-4e6d-47c9-b940-fef91f1f4a05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197660estrogens, conjugated 0.3 MG Oral TabletPSN2b4dbb7c-4e6d-47c9-b940-fef91f1f4a059
208513PREMARIN 0.3 MG Oral TabletPSN2b4dbb7c-4e6d-47c9-b940-fef91f1f4a059
208513estrogens, conjugated (USP) 0.3 MG Oral Tablet [Premarin]SBD2b4dbb7c-4e6d-47c9-b940-fef91f1f4a059
197660estrogens, conjugated (USP) 0.3 MG Oral TabletSCD2b4dbb7c-4e6d-47c9-b940-fef91f1f4a059
208513Premarin 0.3 MG Oral TabletSY2b4dbb7c-4e6d-47c9-b940-fef91f1f4a059

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1853-35009018530330 TABLET, FILM COATED in 1 BOTTLE (50090-1853-3) 2015-06-020000-00-00NoNoCurrent