FDA.reportPublic FDA data

Premarin

Product NDC
0046-0872
11-digit product format
000460872
Labeler code
0046
Product ID
0046-0872_94b7195e-3ce2-4e04-a814-9b63add4896e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
conjugated estrogens
Dosage form
CREAM
Route
VAGINAL
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application
NDA020216
Marketing category
NDA
Marketing start
1978-11-01
Substance
ESTROGENS, CONJUGATED
Active strength
.625 mg/g
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
Brand name suffix
Vaginal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTROGENS, CONJUGATED.625 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIU5QR144QX
Rxcui688240, 688242

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
0046-0872-04PremarinVaginal1 in 1 CARTONCREAM133
0046-0872-04PremarinVaginal4 g in 1 TUBE, WITH APPLICATORCREAM433
0046-0872-21PremarinVaginal1 in 1 CARTONCREAM133
0046-0872-21PremarinVaginal30 g in 1 TUBE, WITH APPLICATORCREAM3033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0046-0872-21GM - Gram0046-0872c9a3ccb5-df04-4261-907b-63460cf8b52e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTROGENS, CONJUGATEDACTIVE INGREDIENTIU5QR144QXPREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
ESTROGENS, CONJUGATEDACTIVE MOIETYIU5QR144QXPREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
METHYL STEARATEINACTIVE INGREDIENT8D4NXF3ZH7PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
PROPYLENE GLYCOL MONOPALMITOSTEARATEINACTIVE INGREDIENTF76354LMGRPREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0046-0872PREMARIN VAGINAL (CONJUGATED ESTROGENS) CREAM [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]32Current NDC, Legacy NDC, 4 package rows20250507_96609623-528e-4aba-cabe-7254aed816d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
688240estrogens, conjugated 0.625 MG/GM Vaginal CreamPSN96609623-528e-4aba-cabe-7254aed816d533
688242premarin 0.625 MG/GM Vaginal CreamPSN96609623-528e-4aba-cabe-7254aed816d533
688242estrogens, conjugated (USP) 0.625 MG/ML Vaginal Cream [Premarin]SBD96609623-528e-4aba-cabe-7254aed816d533
688240estrogens, conjugated (USP) 0.625 MG/ML Vaginal CreamSCD96609623-528e-4aba-cabe-7254aed816d533
688240estrogens, conjugated (USP) 0.0625 % Vaginal CreamSY96609623-528e-4aba-cabe-7254aed816d533
688242Premarin 0.625 MG per GM Vaginal CreamSY96609623-528e-4aba-cabe-7254aed816d533
688242Premarin 0.625 MG/ML Vaginal CreamSY96609623-528e-4aba-cabe-7254aed816d533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0046-0872-04000460872041 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-04) / 4 g in 1 TUBE, WITH APPLICATOR1978-11-010000-00-00NoNoCurrent
0046-0872-21000460872211 TUBE, WITH APPLICATOR in 1 CARTON (0046-0872-21) / 30 g in 1 TUBE, WITH APPLICATOR1978-11-010000-00-00NoNoCurrent