NDC 70710-1543

ZALDYON

Mesalamine

ZALDYON is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Mesalamine.

Product ID70710-1543_3d8c9e18-6688-42be-a135-f2d0a4729dbe
NDC70710-1543
Product TypeHuman Prescription Drug
Proprietary NameZALDYON
Generic NameMesalamine
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-01-17
Marketing CategoryANDA / ANDA
Application NumberANDA203286
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameMESALAMINE
Active Ingredient Strength800 mg/1
Pharm ClassesAminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70710-1543-4

10 BLISTER PACK in 1 CARTON (70710-1543-4) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70710-1543-2)
Marketing Start Date2019-01-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70710-1543-4 [70710154304]

ZALDYON TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203286
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-17

NDC 70710-1543-8 [70710154308]

ZALDYON TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203286
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-17

NDC 70710-1543-2 [70710154302]

ZALDYON TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203286
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-17

Drug Details

Active Ingredients

IngredientStrength
MESALAMINE800 mg/1

OpenFDA Data

SPL SET ID:89eb4706-c347-4bb8-8f89-394dbdec5cd3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2108912
  • 833234
  • Pharmacological Class

    • Aminosalicylate [EPC]
    • Aminosalicylic Acids [CS]

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

    NDCBrand NameGeneric Name
    70710-1543ZALDYONZALDYON
    70771-1353ZALDYONZALDYON
    0023-5901Asacol HDmesalamine
    0430-0783ASACOL HDmesalamine
    0023-5853Delzicolmesalamine
    0179-0142Lialdamesalamine
    0093-5907MesalamineMesalamine
    0093-9224mesalaminemesalamine
    0378-1375Mesalaminemesalamine
    0378-9230Mesalaminemesalamine
    0472-1915MesalamineMesalamine
    0037-0066Rowasamesalamine
    0037-0022sfRowasamesalamine

    Trademark Results [ZALDYON]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZALDYON
    ZALDYON
    87786107 not registered Dead/Abandoned
    Zydus Pharmaceuticals (USA) Inc.
    2018-02-06

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