Premarin

Product NDC
53808-0770
11-digit product format
538080770
Labeler code
53808
Product ID
53808-0770_3144f373-fd53-433e-bcc3-7de919cfb475
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
conjugated estrogens
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA004782
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
ESTROGENS, CONJUGATED
Active strength
1 mg/1
Pharmacologic classes
Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
53808-0770-12019-10-21C16284748780-1956f9ecf-c5eb-621f-e053-dbdaa90a74adPREMARIN ® (conjugated estrogens tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0770-1Premarin30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTROGENS, CONJUGATEDACTIVE INGREDIENTIU5QR144QXPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ESTROGENS, CONJUGATEDACTIVE MOIETYIU5QR144QXPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2208 (15000 CPS)INACTIVE INGREDIENTZ78RG6M2N2PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (15 CPS)INACTIVE INGREDIENT36SFW2JZ0WPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (6 CPS)INACTIVE INGREDIENT0WZ8WG20P6PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SUCROSEINACTIVE INGREDIENTC151H8M554PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0770PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_1fcd61a8-1a67-4785-a51a-45fca6fbb32b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310197estrogens, conjugated 0.625 MG Oral TabletPSN1fcd61a8-1a67-4785-a51a-45fca6fbb32b1
150840PREMARIN 0.625 MG Oral TabletPSN1fcd61a8-1a67-4785-a51a-45fca6fbb32b1
150840estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin]SBD1fcd61a8-1a67-4785-a51a-45fca6fbb32b1
310197estrogens, conjugated (USP) 0.625 MG Oral TabletSCD1fcd61a8-1a67-4785-a51a-45fca6fbb32b1
310197estrogens, conjugated (USP) 625 MCG Oral TabletSY1fcd61a8-1a67-4785-a51a-45fca6fbb32b1
150840Premarin 0.625 MG Oral TabletSY1fcd61a8-1a67-4785-a51a-45fca6fbb32b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0770-15380807700130 in 1 BLISTER PACKHistorical