chlordiazepoxide and amitriptyline hydrochloride (42571-303)

Drug Facts

Product Profile

Brand Name chlordiazepoxide and amitriptyline hydrochloride

Generic Name chlordiazepoxide and amitriptyline hydrochloride

Labeler micro labs limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

amitriptyline hydrochloride 10 mg/1, chlordiazepoxide 25 mg/1

Manufacturer

Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-303

Product ID 42571-303_3747026e-d9b9-7fb3-e063-6394a90a1641

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211925

DEA Schedule civ

Listing Expiration 2026-12-31

Marketing Start 2022-04-01

Pharmacologic Class

Established (EPC)

benzodiazepine [epc]

Chemical Structure

benzodiazepines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571303

Hyphenated Format 42571-303

Supplemental Identifiers

UPC

0342571302016 0342571303013

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 ANDA211925 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1
25 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (42571-303-01)
500 TABLET in 1 BOTTLE (42571-303-05)

source: ndc

Packages (2)

42571-303-01 100 TABLET in 1 BOTTLE (42571-303-01) 42571-303-05 500 TABLET in 1 BOTTLE (42571-303-05)

Ingredients (2)

amitriptyline hydrochloride (10 mg/1) chlordiazepoxide (25 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": "3747026e-d9b9-7fb3-e063-6394a90a1641", "openfda": {"nui": ["N0000175694", "M0002356"], "upc": ["0342571302016", "0342571303013"], "unii": ["6RZ6XEZ3CR", "26LUD4JO9K"], "spl_set_id": ["b20dcdb1-50f4-4d49-a50e-be0308962f5b"], "pharm_class_cs": ["Benzodiazepines [CS]"], "pharm_class_epc": ["Benzodiazepine [EPC]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42571-303-01)", "package_ndc": "42571-303-01", "marketing_start_date": "20220401"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42571-303-05)", "package_ndc": "42571-303-05", "marketing_start_date": "20220401"}], "brand_name": "Chlordiazepoxide and Amitriptyline Hydrochloride", "product_id": "42571-303_3747026e-d9b9-7fb3-e063-6394a90a1641", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Tricyclic Antidepressant [EPC]"], "product_ndc": "42571-303", "dea_schedule": "CIV", "generic_name": "Chlordiazepoxide and Amitriptyline Hydrochloride", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlordiazepoxide and Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "10 mg/1"}, {"name": "CHLORDIAZEPOXIDE", "strength": "25 mg/1"}], "application_number": "ANDA211925", "marketing_category": "ANDA", "marketing_start_date": "20220401", "listing_expiration_date": "20261231"}