NDC 0378-0211

Chlordiazepoxide and Amitriptyline Hydrochloride

Chlordiazepoxide And Amitriptyline Hydrochloride

Chlordiazepoxide and Amitriptyline Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Amitriptyline Hydrochloride; Chlordiazepoxide.

Product ID0378-0211_000b3441-5518-43b7-a8a1-610378b7c501
NDC0378-0211
Product TypeHuman Prescription Drug
Proprietary NameChlordiazepoxide and Amitriptyline Hydrochloride
Generic NameChlordiazepoxide And Amitriptyline Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1986-12-10
Marketing CategoryANDA / ANDA
Application NumberANDA071297
Labeler NameMylan Pharmaceuticals Inc.
Substance NameAMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Active Ingredient Strength14 mg/1; mg/1
Pharm ClassesBenzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-0211-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01)
Marketing Start Date1986-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0211-01 [00378021101]

Chlordiazepoxide and Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA071297
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1986-12-10

NDC 0378-0211-05 [00378021105]

Chlordiazepoxide and Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA071297
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1986-12-10

Drug Details

Active Ingredients

IngredientStrength
CHLORDIAZEPOXIDE5 mg/1

OpenFDA Data

SPL SET ID:66a756f2-ac77-451c-a19a-08896d73b15c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856769
  • 856792
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]
    • Tricyclic Antidepressant [EPC]
    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]
    • Tricyclic Antidepressant [EPC]

    NDC Crossover Matching brand name "Chlordiazepoxide and Amitriptyline Hydrochloride" or generic name "Chlordiazepoxide And Amitriptyline Hydrochloride"

    NDCBrand NameGeneric Name
    0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochloride
    0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochloride
    42571-302Chlordiazepoxide and Amitriptyline HydrochlorideChlordiazepoxide and Amitriptyline Hydrochloride
    42571-303Chlordiazepoxide and Amitriptyline HydrochlorideChlordiazepoxide and Amitriptyline Hydrochloride

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