NDC 31722-005

Mesalamine

Mesalamine

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

Product ID31722-005_e771a2ce-776e-619d-e053-2995a90a0f52
NDC31722-005
Product TypeHuman Prescription Drug
Proprietary NameMesalamine
Generic NameMesalamine
Dosage FormSuppository
Route of AdministrationRECTAL
Marketing Start Date2020-03-19
Marketing CategoryANDA / ANDA
Application NumberANDA213377
Labeler NameCamber Pharmaceuticals, Inc.
Substance NameMESALAMINE
Active Ingredient Strength1000 mg/1
Pharm ClassesAminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 31722-005-30

5 PACKAGE in 1 CARTON (31722-005-30) > 6 SUPPOSITORY in 1 PACKAGE (31722-005-32)
Marketing Start Date2020-03-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 31722-005-31 [31722000531]

Mesalamine SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA213377
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-19

NDC 31722-005-32 [31722000532]

Mesalamine SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA213377
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-19

NDC 31722-005-30 [31722000530]

Mesalamine SUPPOSITORY
Marketing CategoryANDA
Application NumberANDA213377
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-19

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE1000 mg/1

OpenFDA Data

SPL SET ID:efa9d039-ae1f-4cd6-98f2-e87a901dfaeb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248420
    • UPC Code
  • 0331722005302
  • 0331722005319

    • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

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

    NDCBrand NameGeneric Name
    0093-5907MesalamineMesalamine
    0093-9224mesalaminemesalamine
    0378-1375Mesalaminemesalamine
    0378-7401Mesalaminemesalamine Film Coated
    0378-9230Mesalaminemesalamine
    68382-711mesalaminemesalamine
    68382-484mesalaminemesalamine
    68382-435mesalaminemesalamine
    68382-649mesalaminemesalamine
    0591-2245MesalamineMesalamine
    70771-1110mesalaminemesalamine
    70771-1071mesalaminemesalamine
    16714-830mesalaminemesalamine
    45802-923MesalamineMesalamine
    45802-929MesalamineMesalamine
    45802-098MesalamineMesalamine
    50090-3497mesalaminemesalamine
    54092-100MesalamineMesalamine
    59762-0118MesalamineMesalamine
    60687-408MesalamineMesalamine
    60687-397MesalamineMesalamine
    60687-347mesalaminemesalamine
    62559-420MesalamineMesalamine
    63304-175MesalamineMesalamine
    59762-0117MESALAMINEMESALAMINE
    64980-282MesalamineMesalamine
    0781-7088MesalamineMesalamine
    42291-564MesalamineMesalamine
    42291-563MesalamineMesalamine
    68682-113mesalaminemesalamine
    0023-5901Asacol HDmesalamine
    0023-5853Delzicolmesalamine
    0179-0142Lialdamesalamine
    0037-0066Rowasamesalamine
    0037-0022sfRowasamesalamine
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