NDC 0187-0659

Diastat

Diazepam

Diastat is a Rectal Gel in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Diazepam.

Product ID0187-0659_1e7e58ee-24d8-4c34-8e85-7f3a8b425e01
NDC0187-0659
Product TypeHuman Prescription Drug
Proprietary NameDiastat
Generic NameDiazepam
Dosage FormGel
Route of AdministrationRECTAL
Marketing Start Date1997-07-29
Marketing CategoryNDA / NDA
Application NumberNDA020648
Labeler NameBausch Health US, LLC
Substance NameDIAZEPAM
Active Ingredient Strength20 mg/4mL
Pharm ClassesBenzodiazepine [EPC], Benzodiazepines [CS]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0187-0659-20

2 SYRINGE, PLASTIC in 1 PACKAGE (0187-0659-20) > 4 mL in 1 SYRINGE, PLASTIC
Marketing Start Date1997-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-0659-20 [00187065920]

Diastat GEL
Marketing CategoryNDA
Application NumberNDA020648
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-07-29

Drug Details

Active Ingredients

IngredientStrength
DIAZEPAM20 mg/4mL

OpenFDA Data

SPL SET ID:a84a73a7-8e3a-4985-8be0-04b3028f5e49
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 801966
  • 801965
  • 801962
  • 801961
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]

    NDC Crossover Matching brand name "Diastat" or generic name "Diazepam"

    NDCBrand NameGeneric Name
    0187-0658Diastatdiazepam
    0187-0659Diastatdiazepam
    66490-650DiastatDiastat
    0054-3188DiazepamDiazepam
    0093-6137DiazepamDiazepam
    0093-6138DiazepamDiazepam
    0093-6139DiazepamDiazepam
    0121-0905DiazepamDiazepam
    0172-3925DiazepamDiazepam
    0172-3926DiazepamDiazepam
    0172-3927DiazepamDiazepam
    0140-0004Valiumdiazepam
    0140-0005Valiumdiazepam
    0140-0006Valiumdiazepam

    Trademark Results [Diastat]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DIASTAT
    DIASTAT
    74466201 1930258 Live/Registered
    W. L. GORE & ASSOCIATES, INC.
    1993-11-30
    DIASTAT
    DIASTAT
    74262163 1819386 Live/Registered
    VALEANT PHARMACEUTICALS NORTH AMERICA LLC
    1992-04-03
    DIASTAT
    DIASTAT
    74098242 not registered Dead/Abandoned
    Shield Diagnostics Limited
    1990-09-18
    DIASTAT
    DIASTAT
    73634852 1487175 Dead/Cancelled
    DIANON SYSTEMS, INC.
    1986-12-11
    DIASTAT
    DIASTAT
    73357893 1229474 Dead/Cancelled
    ADAC Laboratories
    1982-04-02

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.