NDC 0440-5295

Raloxifene Hydrochloride

Raloxifene Hydrochloride

Raloxifene Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Liberty Pharmaceuticals, Inc.. The primary component is Raloxifene Hydrochloride.

Product ID0440-5295_3a9a9dae-0c0a-465f-887a-bd7454e4c79c
NDC0440-5295
Product TypeHuman Prescription Drug
Proprietary NameRaloxifene Hydrochloride
Generic NameRaloxifene Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-11-12
Marketing CategoryANDA / ANDA
Application NumberANDA090842
Labeler NameLiberty Pharmaceuticals, Inc.
Substance NameRALOXIFENE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesEstrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0440-5295-01

100 TABLET, FILM COATED in 1 BOTTLE (0440-5295-01)
Marketing Start Date2014-11-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0440-5295-30 [00440529530]

Raloxifene Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090842
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-12
Inactivation Date2020-01-31

NDC 0440-5295-05 [00440529505]

Raloxifene Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090842
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-12
Inactivation Date2020-01-31

NDC 0440-5295-81 [00440529581]

Raloxifene Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090842
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-12
Inactivation Date2020-01-31

NDC 0440-5295-01 [00440529501]

Raloxifene Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090842
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-12
Inactivation Date2020-01-31

NDC 0440-5295-60 [00440529560]

Raloxifene Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090842
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-12
Inactivation Date2020-01-31

NDC 0440-5295-90 [00440529590]

Raloxifene Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090842
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-12
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
RALOXIFENE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:c9b60ef1-c88b-4363-9a28-5854b7ff8a50
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1490065
  • Pharmacological Class

    • Estrogen Agonist/Antagonist [EPC]
    • Selective Estrogen Receptor Modulators [MoA]

    NDC Crossover Matching brand name "Raloxifene Hydrochloride" or generic name "Raloxifene Hydrochloride"

    NDCBrand NameGeneric Name
    0093-7290Raloxifene HydrochlorideRaloxifene Hydrochloride
    0440-5295Raloxifene HydrochlorideRaloxifene Hydrochloride
    0904-6902Raloxifene hydrochlorideRaloxifene hydrochloride
    16714-213Raloxifene HydrochlorideRaloxifene Hydrochloride
    31722-256Raloxifene HydrochlorideRaloxifene Hydrochloride
    42291-726Raloxifene HydrochlorideRaloxifene Hydrochloride
    43353-253Raloxifene HydrochlorideRaloxifene Hydrochloride
    43598-505Raloxifene hydrochlorideRaloxifene hydrochloride
    50090-3363Raloxifene hydrochlorideRaloxifene hydrochloride
    50090-3866Raloxifene HydrochlorideRaloxifene Hydrochloride
    50090-5458Raloxifene HydrochlorideRaloxifene
    50090-6177Raloxifene hydrochlorideRaloxifene hydrochloride
    50228-306Raloxifene hydrochlorideRaloxifene hydrochloride
    50268-694Raloxifene HydrochlorideRaloxifene Hydrochloride
    52343-137Raloxifene HydrochlorideRaloxifene Hydrochloride
    60687-266Raloxifene HydrochlorideRaloxifene
    63629-7708Raloxifene HydrochlorideRaloxifene
    63629-8209Raloxifene HydrochlorideRaloxifene Hydrochloride
    68462-393raloxifene hydrochlorideraloxifene hydrochloride
    69097-825Raloxifene HydrochlorideRaloxifene Hydrochloride
    71610-053Raloxifene hydrochlorideRaloxifene hydrochloride
    76282-256Raloxifene HydrochlorideRaloxifene Hydrochloride
    65162-057Raloxifene HydrochlorideRaloxifene Hydrochloride
    65862-709Raloxifene HydrochlorideRaloxifene Hydrochloride
    66993-661Raloxifene HydrochlorideRaloxifene Hydrochloride
    71335-1460Raloxifene hydrochlorideRaloxifene hydrochloride
    70518-2994Raloxifene HydrochlorideRaloxifene Hydrochloride
    71335-1715Raloxifene HydrochlorideRaloxifene Hydrochloride
    71209-082Raloxifene hydrochlorideRaloxifene hydrochloride
    71610-504Raloxifene HydrochlorideRaloxifene Hydrochloride
    71335-1663Raloxifene HydrochlorideRaloxifene Hydrochloride
    0002-4184EvistaRaloxifene hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.