NDC 0485-0082

ED-SPAZ

Hyoscyamine Sulfate

ED-SPAZ is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is Hyoscyamine Sulfate.

Product ID0485-0082_61698d95-9cbf-7582-e053-2a91aa0a06a8
NDC0485-0082
Product TypeHuman Prescription Drug
Proprietary NameED-SPAZ
Generic NameHyoscyamine Sulfate
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2010-05-12
Marketing CategoryUNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
Labeler NameEDWARDS PHARMACEUTICALS, INC.
Substance NameHYOSCYAMINE SULFATE
Active Ingredient Strength0 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0485-0082-01

100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0485-0082-01)
Marketing Start Date2010-05-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0485-0082-01 [00485008201]

ED-SPAZ TABLET, ORALLY DISINTEGRATING
Marketing Categoryunapproved drug other
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-05-12
Inactivation Date2020-01-31
Reactivation Date2020-03-30

Drug Details

Active Ingredients

IngredientStrength
HYOSCYAMINE SULFATE.125 mg/1

OpenFDA Data

SPL SET ID:f33a4774-9fbb-4782-a7e1-068e83b7504d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046985
  • 1048058

    • NDC Crossover Matching brand name "ED-SPAZ" or generic name "Hyoscyamine Sulfate"

    NDCBrand NameGeneric Name
    0485-0082ED-SPAZHYOSCYAMINE SULFATE
    0225-0295ANASPAZHYOSCYAMINE SULFATE
    39328-047HyoscyamineHyoscyamine Sulfate
    39328-048HyoscyamineHyoscyamine Sulfate
    21695-442Hyoscyamine SulfateHyoscyamine Sulfate
    21695-926Hyoscyamine SulfateHyoscyamine Sulfate
    43063-321Hyoscyamine SulfateHyoscyamine Sulfate
    43199-011Hyoscyamine SulfateHyoscyamine Sulfate
    43199-012Hyoscyamine SulfateHyoscyamine Sulfate
    42192-338Hyoscyamine Sulfate ODThyoscyamine sulfate
    42192-339Hyoscyamine Sulfate SLhyoscyamine sulfate
    42192-340Hyoscyamine Sulfate TABhyoscyamine sulfate
    17856-0511HyosyneHyoscyamine Sulfate
    17856-0514HyosyneHyoscyamine Sulfate
    0037-9001LevsinHYOSCYAMINE SULFATE

    Trademark Results [ED-SPAZ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ED-SPAZ
    ED-SPAZ
    86300834 4671049 Live/Registered
    Edwards Pharmaceuticals, Inc.
    2014-06-05
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.