FDA.reportPublic FDA data

Prempro

Product NDC
68258-5980
11-digit product format
682585980
Labeler code
68258
Product ID
68258-5980_cb3ae439-62fe-48c7-94de-a6e5f518a973
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
conjugated estrogens and medroxyprogesterone acetate
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
NDA020527
Marketing category
NDA
Marketing start
2009-09-21
Marketing end
0000-00-00
Substance
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Active strength
1 mg/1; mg/1
Pharmacologic classes
Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS],Progesterone Congeners [CS],Progestin [EPC]
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
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dceProduct name620240606
d95be220-b30e-4165-a12d-f83825b0efb1Product name120160111
882e78d5-69f7-4a43-812f-1c1628241bbcProduct name120150910
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2Product name120140508
2e1ce74f-4938-37b4-e2b4-cfd7971b45eaProduct name120140508
51a98800-9a04-9e42-2219-e588f17f9e48Product name120140508
d90784c3-64a2-2f23-9acd-d948d25bf235Product name120140508
f363ed61-d8ad-8f59-ee92-52a12578e008Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68258-5980-22019-11-27C16284748780-19855d018-ebdf-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use PREMPRO/PREMPHASE safely and effectively. See full prescribing information for PREMPRO/PREMPHASE. PREMPRO ® (conjugated estrogens/medroxyprogesterone acetate tablets) PREMPHASE ® (conjugated estrogens plus medroxyprogesterone acetate tablets) Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-5980-2Prempro28 in 1 BLISTER PACKTABLET, SUGAR COATED283
68258-5980-2Prempro1 in 1 CARTONTABLET, SUGAR COATED13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTROGENS, CONJUGATEDACTIVE INGREDIENTIU5QR144QXPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
ESTROGENS, CONJUGATEDACTIVE MOIETYIU5QR144QXPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-5980PREMPRO (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE) TABLET, SUGAR COATED [DISPENSING SOLUTIONS, INC.]3Legacy NDC, 2 package rows20130314_198d547d-c985-46bc-a66f-e3182a294cb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000491{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } Pack [Prempro 0.3/1.5 28 Day]BPCK198d547d-c985-46bc-a66f-e3182a294cb53
1000499{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } Pack [Prempro 0.625/2.5 28 Day]BPCK198d547d-c985-46bc-a66f-e3182a294cb53
1000490{28 (estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet) } PackGPCK198d547d-c985-46bc-a66f-e3182a294cb53
1000395{28 (estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral Tablet) } PackGPCK198d547d-c985-46bc-a66f-e3182a294cb53
1000490Estrogens Conj-Medroxyprogest Ac 0.3-1.5 MG (28) Oral Tablet 28 Day PackPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000395Estrogens Conj-Medroxyprogest Ac 0.625-2.5 MG (28) Oral Tablet 28 Day PackPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000351estrogens, conjugated 0.3 MG / medroxyPROGESTERone acetate 1.5 MG Oral TabletPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000355estrogens, conjugated 0.625 MG / medroxyPROGESTERone acetate 2.5 MG Oral TabletPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000491PREMPRO 0.3/1.5 28 Day PackPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000499PREMPRO 0.625/2.5 28 Day PackPSN198d547d-c985-46bc-a66f-e3182a294cb53
1000351estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral TabletSCD198d547d-c985-46bc-a66f-e3182a294cb53
1000355estrogens, conjugated (USP) 0.625 MG / medroxyprogesterone acetate 2.5 MG Oral TabletSCD198d547d-c985-46bc-a66f-e3182a294cb53
1000491Prempro 0.3/1.5 28 Day PackSY198d547d-c985-46bc-a66f-e3182a294cb53
1000499Prempro 0.625/2.5 28 Day PackSY198d547d-c985-46bc-a66f-e3182a294cb53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-5980-26825859800228 in 1 BLISTER PACKHistorical