FDA.reportPublic FDA data

Premarin

Product NDC
50090-0167
11-digit product format
500900167
Labeler code
50090
Product ID
50090-0167_3438144a-8319-4971-981b-38f13201b980
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
.625 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.625 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIU5QR144QX
Rxcui150840, 310197

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0167-0Premarin100 in 1 BOTTLETABLET, FILM COATED10023
50090-0167-5Premarin30 in 1 BOTTLETABLET, FILM COATED3023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0167-5EA - Each50090-0167ccf2f471-e9cb-4da3-af85-3ee0ebbe0c7612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0167PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]23Current NDC, Legacy NDC, 2 package rows20250406_a3b86b85-8923-42ae-aa31-a66a6e090327.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310197estrogens, conjugated 0.625 MG Oral TabletPSNa3b86b85-8923-42ae-aa31-a66a6e09032723
150840PREMARIN 0.625 MG Oral TabletPSNa3b86b85-8923-42ae-aa31-a66a6e09032723
150840estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin]SBDa3b86b85-8923-42ae-aa31-a66a6e09032723
310197estrogens, conjugated (USP) 0.625 MG Oral TabletSCDa3b86b85-8923-42ae-aa31-a66a6e09032723
310197estrogens, conjugated (USP) 625 MCG Oral TabletSYa3b86b85-8923-42ae-aa31-a66a6e09032723
150840Premarin 0.625 MG Oral TabletSYa3b86b85-8923-42ae-aa31-a66a6e09032723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0167-050090016700100 TABLET, FILM COATED in 1 BOTTLE (50090-0167-0) 2018-10-290000-00-00NoNoCurrent
50090-0167-55009001670530 TABLET, FILM COATED in 1 BOTTLE (50090-0167-5) 2016-06-210000-00-00NoNoCurrent