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  5. NDC Package Code: 0378-0277-05 Chlordiazepoxide And Amitriptyline Hydrochloride

NDC Package 0378-0277-05 Chlordiazepoxide And Amitriptyline Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0378-0277-05
Package Description:
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
0378-0277
Proprietary Name:
Chlordiazepoxide And Amitriptyline Hydrochloride
Non-Proprietary Name:
Chlordiazepoxide And Amitriptyline Hydrochloride
Substance Name:
Amitriptyline Hydrochloride; Chlordiazepoxide
Usage Information:
Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety.The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablets occur earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone.Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.
11-Digit NDC Billing Format:
00378027705
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
500 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 856769 - chlordiazePOXIDE 5 MG / amitriptyline HCl 12.5 MG Oral Tablet
  • RxCUI: 856769 - amitriptyline hydrochloride 12.5 MG / chlordiazepoxide 5 MG Oral Tablet
  • RxCUI: 856792 - chlordiazePOXIDE 10 MG / amitriptyline HCl 25 MG Oral Tablet
  • RxCUI: 856792 - amitriptyline hydrochloride 25 MG / chlordiazepoxide 10 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan Pharmaceuticals Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMITRIPTYLINE HYDROCHLORIDE 27.98 mg/1
  • CHLORDIAZEPOXIDE 10 mg/1
    • Pharmacologic Class(es):
  • Benzodiazepine - [EPC] (Established Pharmacologic Class)
  • Benzodiazepines - [CS]
  • Tricyclic Antidepressant - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA071297
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-10-1986
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0378-0277-01100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0378-0277-05?

    The NDC Packaged Code 0378-0277-05 is assigned to a package of 500 tablet, film coated in 1 bottle, plastic of Chlordiazepoxide And Amitriptyline Hydrochloride, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0378-0277 included in the NDC Directory?

    Yes, Chlordiazepoxide And Amitriptyline Hydrochloride with product code 0378-0277 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on December 10, 1986 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0378-0277-05?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 500.

    What is the 11-digit format for NDC 0378-0277-05?

    The 11-digit format is 00378027705. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20378-0277-055-4-200378-0277-05