chlordiazepoxide and amitriptyline hydrochloride (42571-302)

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 5 mg/1, chlordiazepoxide 12.5 mg/1

Manufacturer

Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-302

Product ID 42571-302_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 42571302

Hyphenated Format 42571-302

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

5 mg/1
12.5 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (42571-302-01)
500 TABLET in 1 BOTTLE (42571-302-05)

source: ndc

Packages (2)

42571-302-01 100 TABLET in 1 BOTTLE (42571-302-01) 42571-302-05 500 TABLET in 1 BOTTLE (42571-302-05)

Ingredients (2)

amitriptyline hydrochloride (5 mg/1) chlordiazepoxide (12.5 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": "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 (42571-302-01)", "package_ndc": "42571-302-01", "marketing_start_date": "20220401"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (42571-302-05)", "package_ndc": "42571-302-05", "marketing_start_date": "20220401"}], "brand_name": "Chlordiazepoxide and Amitriptyline Hydrochloride", "product_id": "42571-302_3747026e-d9b9-7fb3-e063-6394a90a1641", "dosage_form": "TABLET", "pharm_class": ["Benzodiazepine [EPC]", "Benzodiazepines [CS]", "Tricyclic Antidepressant [EPC]"], "product_ndc": "42571-302", "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": "5 mg/1"}, {"name": "CHLORDIAZEPOXIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA211925", "marketing_category": "ANDA", "marketing_start_date": "20220401", "listing_expiration_date": "20261231"}