NDC 69918-560

Mesalamine Rectal

Mesalamine

Mesalamine Rectal is a Rectal Suppository in the Human Prescription Drug category. It is labeled and distributed by Amring Pharmaceuticals Inc.. The primary component is Mesalamine.

Product ID69918-560_32848219-33c4-468e-b60e-e13caf9ebe02
NDC69918-560
Product TypeHuman Prescription Drug
Proprietary NameMesalamine Rectal
Generic NameMesalamine
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2019-06-24
Marketing CategoryANDA / ANDA
Application NumberANDA208362
Labeler NameAmring Pharmaceuticals Inc.
Substance NameMESALAMINE
Active Ingredient Strength1000 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69918-560-30

30 SUPPOSITORY in 1 BOX (69918-560-30)
Marketing Start Date2019-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69918-560-30 [69918056030]

Mesalamine Rectal SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA208362
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-24

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE1000 mg/1

OpenFDA Data

SPL SET ID:87de237c-febb-42ca-b2a4-b444396f8640
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248420
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

    NDC Crossover Matching brand name "Mesalamine Rectal" or generic name "Mesalamine"

    NDCBrand NameGeneric Name
    69918-560Mesalamine RectalMesalamine Rectal
    0023-5901Asacol HDmesalamine
    0430-0783ASACOL HDmesalamine
    0023-5853Delzicolmesalamine
    0179-0142Lialdamesalamine
    0093-5907MesalamineMesalamine
    0093-9224mesalaminemesalamine
    0378-1375Mesalaminemesalamine
    0378-9230Mesalaminemesalamine
    0472-1915MesalamineMesalamine
    0037-0066Rowasamesalamine
    0037-0022sfRowasamesalamine

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