FDA.reportPublic FDA data

Premarin

Product NDC
0046-1103
11-digit product format
000461103
Labeler code
0046
Product ID
0046-1103_7273b788-92aa-4d38-8812-33edaf21bd42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estrogens, conjugated
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application
NDA004782
Marketing category
NDA
Marketing start
2006-01-01
Substance
ESTROGENS, CONJUGATED
Active strength
.9 mg/1
Pharmacologic classes
Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Premarin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTROGENS, CONJUGATED.9 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIU5QR144QX
Rxcui150840, 197660, 197661, 197662, 202301, 208513, 208949, 310197, 403849, 404550

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
0046-1103-81Premarin100 in 1 BOTTLETABLET, FILM COATED10036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0046-1103-81EA - Each0046-11039125c986-1340-43e6-9a32-9b1cf377c5d712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTROGENS, CONJUGATEDACTIVE INGREDIENTIU5QR144QXPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
ESTROGENS, CONJUGATEDACTIVE MOIETYIU5QR144QXPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
SUCROSEINACTIVE INGREDIENTC151H8M554PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]21
ESTROGENS, CONJUGATEDACTIVE INGREDIENTIU5QR144QXPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ESTROGENS, CONJUGATEDACTIVE MOIETYIU5QR144QXPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0046-1103PREMARIN (ESTROGENS, CONJUGATED) TABLET, FILM COATED [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]35Current NDC, Legacy NDC, 1 package rows20250508_258e1602-a3cf-4ccc-ca80-73dbbfb812ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197660estrogens, conjugated 0.3 MG Oral TabletPSNb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
403849estrogens, conjugated 0.45 MG Oral TabletPSNb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
310197estrogens, conjugated 0.625 MG Oral TabletPSNb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
197661estrogens, conjugated 0.9 MG Oral TabletPSNb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
197662estrogens, conjugated 1.25 MG Oral TabletPSNb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
208513PREMARIN 0.3 MG Oral TabletPSNb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
404550PREMARIN 0.45 MG Oral TabletPSNb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
150840PREMARIN 0.625 MG Oral TabletPSNb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
208949PREMARIN 0.9 MG Oral TabletPSNb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
202301PREMARIN 1.25 MG Oral TabletPSNb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
208513estrogens, conjugated (USP) 0.3 MG Oral Tablet [Premarin]SBDb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
404550estrogens, conjugated (USP) 0.45 MG Oral Tablet [Premarin]SBDb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
150840estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin]SBDb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
208949estrogens, conjugated (USP) 0.9 MG Oral Tablet [Premarin]SBDb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
202301estrogens, conjugated (USP) 1.25 MG Oral Tablet [Premarin]SBDb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
197660estrogens, conjugated (USP) 0.3 MG Oral TabletSCDb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
403849estrogens, conjugated (USP) 0.45 MG Oral TabletSCDb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
310197estrogens, conjugated (USP) 0.625 MG Oral TabletSCDb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
197661estrogens, conjugated (USP) 0.9 MG Oral TabletSCDb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
197662estrogens, conjugated (USP) 1.25 MG Oral TabletSCDb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
310197estrogens, conjugated (USP) 625 MCG Oral TabletSYb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
208513Premarin 0.3 MG Oral TabletSYb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
404550Premarin 0.45 MG Oral TabletSYb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
150840Premarin 0.625 MG Oral TabletSYb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
208949Premarin 0.9 MG Oral TabletSYb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3
202301Premarin 1.25 MG Oral TabletSYb32fcb1b-fee4-44b8-a91c-10dfdd3f84ea3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0046-1103-8100046110381100 TABLET, FILM COATED in 1 BOTTLE (0046-1103-81) 2006-01-010000-00-00NoNoCurrent