NDC 0187-4100

Librax

Chlordiazepoxide Hydrochloride And Clidinium Bromide

Librax is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Chlordiazepoxide Hydrochloride; Clidinium Bromide.

Product ID0187-4100_02209795-4ee1-4867-9643-5b3351efe2e6
NDC0187-4100
Product TypeHuman Prescription Drug
Proprietary NameLibrax
Generic NameChlordiazepoxide Hydrochloride And Clidinium Bromide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1966-09-01
Marketing CategoryNDA / NDA
Application NumberNDA012750
Labeler NameBausch Health US LLC
Substance NameCHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesBenzodiazepine [EPC],Benzodiazepines [CS],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0187-4100-10

100 CAPSULE in 1 BOTTLE (0187-4100-10)
Marketing Start Date1966-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-4100-10 [00187410010]

Librax CAPSULE
Marketing CategoryNDA
Application NumberNDA012750
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1966-09-01

Drug Details

Active Ingredients

IngredientStrength
CHLORDIAZEPOXIDE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:f99ebf66-f207-4a97-9666-4da1d72b061c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 889614
  • 889616
  • UPC Code
  • 0301874100101
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]
    • Anticholinergic [EPC]
    • Decreased Parasympathetic Acetylcholine Activity [PE]
    • GI Motility Alteration [PE]
    • Digestive/GI System Activity Alteration [PE]
    • Cholinergic Antagonists [MoA]

    NDC Crossover Matching brand name "Librax" or generic name "Chlordiazepoxide Hydrochloride And Clidinium Bromide"

    NDCBrand NameGeneric Name
    0187-4100LibraxChlordiazepoxide Hydrochloride and Clidinium Bromide
    10135-622Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    11534-197Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    23155-808chlordiazepoxide hydrochloride and clidinium bromidechlordiazepoxide hydrochloride and clidinium bromide
    42494-409Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    42582-300Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    42582-301Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    43598-706Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    50090-1528Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    50090-6310Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    51293-607Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    60219-1677chlordiazepoxide hydrochloride and clidinium bromidechlordiazepoxide hydrochloride and clidinium bromide
    60687-639Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    62135-696CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDEChlordiazepoxide Hydrochloride and Clidinium Bromide
    63629-2146Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    63629-2373Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    63629-8859Chlordiazepoxide Hydrochloride and Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    50090-0131Chlordiazepoxide Hydrochloride/Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    51293-696Chlordiazepoxide Hydrochloride/Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide
    63629-2021Chlordiazepoxide Hydrochloride/Clidinium BromideChlordiazepoxide Hydrochloride and Clidinium Bromide

    Trademark Results [Librax]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LIBRAX
    LIBRAX
    72113999 0719562 Live/Registered
    Hoffmann-La Roche Inc.
    1961-02-20

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