NDC 43353-688

Premarin

Conjugated Estrogens

Premarin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Inc.. The primary component is Estrogens, Conjugated.

Product ID43353-688_950b1a7a-07f6-4741-9846-0e2f7e798e3e
NDC43353-688
Product TypeHuman Prescription Drug
Proprietary NamePremarin
Generic NameConjugated Estrogens
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-01-01
Marketing CategoryNDA / NDA
Application NumberNDA004782
Labeler NameAphena Pharma Solutions - Tennessee, Inc.
Substance NameESTROGENS, CONJUGATED
Active Ingredient Strength1 mg/1
Pharm ClassesEstrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 43353-688-60

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-688-60)
Marketing Start Date2006-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-688-60 [43353068860]

Premarin TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA004782
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-01-01
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
ESTROGENS, CONJUGATED.625 mg/1

OpenFDA Data

SPL SET ID:751b6213-92d8-40f8-a2d5-83e8dad086dd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310197
  • 150840
  • 197660
  • 208513

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Premarin" or generic name "Conjugated Estrogens"

    NDCBrand NameGeneric Name
    0046-0749PremarinCONJUGATED ESTROGENS
    0046-0872Premarinconjugated estrogens
    0046-1100Premarinestrogens, conjugated
    0046-1101Premarinestrogens, conjugated
    0046-1102Premarinestrogens, conjugated
    0046-1103Premarinestrogens, conjugated
    0046-1104Premarinestrogens, conjugated
    43353-687Premarinconjugated estrogens
    43353-688Premarinconjugated estrogens
    50090-0167Premarinestrogens, conjugated
    50090-1853Premarinestrogens, conjugated
    53808-0770Premarinconjugated estrogens

    Trademark Results [Premarin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PREMARIN
    PREMARIN
    78352240 not registered Dead/Abandoned
    Wyeth
    2004-01-15
    PREMARIN
    PREMARIN
    71474773 0412696 Dead/Cancelled
    AYERST, MCKENNA & HARRISON LIMITED
    1944-10-02
    PREMARIN
    PREMARIN
    71452899 0397925 Live/Registered
    AYERST, McKENNA & HARRISON (UNITED STATES) LIMITED
    1942-05-09
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