NDC 68258-5980

Prempro

Conjugated Estrogens And Medroxyprogesterone Acetate

Prempro is a Oral Tablet, Sugar Coated in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Estrogens, Conjugated; Medroxyprogesterone Acetate.

Product ID68258-5980_cb3ae439-62fe-48c7-94de-a6e5f518a973
NDC68258-5980
Product TypeHuman Prescription Drug
Proprietary NamePrempro
Generic NameConjugated Estrogens And Medroxyprogesterone Acetate
Dosage FormTablet, Sugar Coated
Route of AdministrationORAL
Marketing Start Date2009-09-21
Marketing CategoryNDA / NDA
Application NumberNDA020527
Labeler NameDispensing Solutions, Inc.
Substance NameESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Active Ingredient Strength1 mg/1; mg/1
Pharm ClassesEstrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS],Progesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68258-5980-2

1 BLISTER PACK in 1 CARTON (68258-5980-2) > 28 TABLET, SUGAR COATED in 1 BLISTER PACK
Marketing Start Date2009-09-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68258-5980-2 [68258598002]

Prempro TABLET, SUGAR COATED
Marketing CategoryNDA
Application NumberNDA020527
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-21
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
ESTROGENS, CONJUGATED.625 mg/1

OpenFDA Data

SPL SET ID:198d547d-c985-46bc-a66f-e3182a294cb5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000355
  • 1000395
  • 1000491
  • 1000490
  • 1000351
  • 1000499
  • Pharmacological Class

    • Estrogen [EPC]
    • Estrogen Receptor Agonists [MoA]
    • Estrogens
    • Conjugated (USP) [CS]
    • Progesterone Congeners [CS]
    • Progestin [EPC]

    NDC Crossover Matching brand name "Prempro" or generic name "Conjugated Estrogens And Medroxyprogesterone Acetate"

    NDCBrand NameGeneric Name
    0046-1105Premproconjugated estrogens and medroxyprogesterone acetate
    0046-1106Premproconjugated estrogens and medroxyprogesterone acetate
    0046-1107Premproconjugated estrogens and medroxyprogesterone acetate
    0046-1108Premproconjugated estrogens and medroxyprogesterone acetate
    50090-0573PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE
    68258-5978Premproconjugated estrogens and medroxyprogesterone acetate
    68258-5980Premproconjugated estrogens and medroxyprogesterone acetate
    69189-1107PremproCONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE
    0046-2575Premphaseconjugated estrogens and medroxyprogesterone acetate

    Trademark Results [Prempro]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PREMPRO
    PREMPRO
    78778200 3217356 Live/Registered
    WYETH LLC
    2005-12-21
    PREMPRO
    PREMPRO
    74524810 not registered Dead/Abandoned
    American Home Products Corporation
    1994-05-16

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