NDC 0037-0066

Rowasa

Mesalamine

Rowasa is a Rectal Suspension in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Mesalamine.

Product ID0037-0066_25b355a1-136b-42d5-bc09-214387ac6784
NDC0037-0066
Product TypeHuman Prescription Drug
Proprietary NameRowasa
Generic NameMesalamine
Dosage FormSuspension
Route of AdministrationRECTAL
Marketing Start Date2016-03-29
Marketing CategoryNDA / NDA
Application NumberNDA019618
Labeler NameMeda Pharmaceuticals
Substance NameMESALAMINE
Active Ingredient Strength4 g/60mL
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0037-0066-03

28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) > 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)
Marketing Start Date2016-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0037-0066-05 [00037006605]

Rowasa SUSPENSION
Marketing CategoryNDA
Application NumberNDA019618
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-29

NDC 0037-0066-06 [00037006606]

Rowasa SUSPENSION
Marketing CategoryNDA
Application NumberNDA019618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-29

NDC 0037-0066-03 [00037006603]

Rowasa SUSPENSION
Marketing CategoryNDA
Application NumberNDA019618
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-29

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE4 g/60mL

OpenFDA Data

SPL SET ID:e505ab99-1943-4216-a178-4d5dbe64e3b2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238151
  • 206798
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]
    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

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

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

    Trademark Results [Rowasa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ROWASA
    ROWASA
    73645784 1461626 Live/Registered
    REID-ROWELL, INC.
    1987-02-20

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