Premarin

Product NDC
43353-688
11-digit product format
433530688
Labeler code
43353
Product ID
43353-688_950b1a7a-07f6-4741-9846-0e2f7e798e3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
conjugated estrogens
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, Inc.
Application
NDA004782
Marketing category
NDA
Marketing start
2006-01-01
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
43353-688-602019-11-13C16284748780-197449f38-c4b5-f6ea-e053-dbdaa90aa703PREMARIN ® (conjugated estrogens tablets, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-688-60Premarin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-688-60EA - Each43353-688cbae4197-5e32-4de1-9816-9801c5d4e27b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTROGENS, CONJUGATEDACTIVE INGREDIENTIU5QR144QXPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
ESTROGENS, CONJUGATEDACTIVE MOIETYIU5QR144QXPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-688PREMARIN (CONJUGATED ESTROGENS) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1Legacy NDC, 1 package rows20120813_751b6213-92d8-40f8-a2d5-83e8dad086dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197660estrogens, conjugated 0.3 MG Oral TabletPSN751b6213-92d8-40f8-a2d5-83e8dad086dd1
310197estrogens, conjugated 0.625 MG Oral TabletPSN751b6213-92d8-40f8-a2d5-83e8dad086dd1
208513PREMARIN 0.3 MG Oral TabletPSN751b6213-92d8-40f8-a2d5-83e8dad086dd1
150840PREMARIN 0.625 MG Oral TabletPSN751b6213-92d8-40f8-a2d5-83e8dad086dd1
208513estrogens, conjugated (USP) 0.3 MG Oral Tablet [Premarin]SBD751b6213-92d8-40f8-a2d5-83e8dad086dd1
150840estrogens, conjugated (USP) 0.625 MG Oral Tablet [Premarin]SBD751b6213-92d8-40f8-a2d5-83e8dad086dd1
197660estrogens, conjugated (USP) 0.3 MG Oral TabletSCD751b6213-92d8-40f8-a2d5-83e8dad086dd1
310197estrogens, conjugated (USP) 0.625 MG Oral TabletSCD751b6213-92d8-40f8-a2d5-83e8dad086dd1
310197estrogens, conjugated (USP) 625 MCG Oral TabletSY751b6213-92d8-40f8-a2d5-83e8dad086dd1
208513Premarin 0.3 MG Oral TabletSY751b6213-92d8-40f8-a2d5-83e8dad086dd1
150840Premarin 0.625 MG Oral TabletSY751b6213-92d8-40f8-a2d5-83e8dad086dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-688-604335306886090 in 1 BOTTLE, PLASTICHistorical