chlordiazepoxide and amitriptyline hydrochloride (0378-0211)

Drug Facts

Product Profile

Brand Name chlordiazepoxide and amitriptyline hydrochloride

Generic Name chlordiazepoxide and amitriptyline hydrochloride

Labeler mylan pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

amitriptyline hydrochloride 14 mg/1, chlordiazepoxide 5 mg/1

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0211

Product ID 0378-0211_efc5a530-785e-4b88-80e9-00c92e2f1fd4

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA071297

DEA Schedule civ

Listing Expiration 2026-12-31

Marketing Start 1986-12-10

Pharmacologic Class

Established (EPC)

benzodiazepine [epc]

Chemical Structure

benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03780211

Hyphenated Format 0378-0211

Supplemental Identifiers

RxCUI

856769 856792

UNII

6RZ6XEZ3CR 26LUD4JO9K

NUI

N0000175694 M0002356

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name chlordiazepoxide and amitriptyline hydrochloride (source: ndc)

Generic Name chlordiazepoxide and amitriptyline hydrochloride (source: ndc)

Application Number ANDA071297 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

14 mg/1
5 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01)
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-05)

source: ndc

Packages (2)

0378-0211-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01) 0378-0211-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-05)

Ingredients (2)

amitriptyline hydrochloride (14 mg/1) chlordiazepoxide (5 mg/1)

Linked Drug Pages (1)

Chlordiazepoxide and Amitriptyline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "efc5a530-785e-4b88-80e9-00c92e2f1fd4", "openfda": {"nui": ["N0000175694", "M0002356"], "unii": ["6RZ6XEZ3CR", "26LUD4JO9K"], "rxcui": ["856769", "856792"], "spl_set_id": ["66a756f2-ac77-451c-a19a-08896d73b15c"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-01)", "package_ndc": "0378-0211-01", "marketing_start_date": "19861210"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0211-05)", "package_ndc": "0378-0211-05", "marketing_start_date": "19861210"}], "brand_name": "Chlordiazepoxide and Amitriptyline Hydrochloride", "product_id": "0378-0211_efc5a530-785e-4b88-80e9-00c92e2f1fd4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Tricyclic Antidepressant [EPC]"], "product_ndc": "0378-0211", "dea_schedule": "CIV", "generic_name": "chlordiazepoxide and amitriptyline hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlordiazepoxide and Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "14 mg/1"}, {"name": "CHLORDIAZEPOXIDE", "strength": "5 mg/1"}], "application_number": "ANDA071297", "marketing_category": "ANDA", "marketing_start_date": "19861210", "listing_expiration_date": "20261231"}