amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: centaur pharmaceuticals private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler centaur pharmaceuticals private limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 150 mg/1

Manufacturer
Centaur Pharmaceuticals Private Limited

Identifiers & Regulatory

Product NDC 64330-635
Product ID 64330-635_0a294e70-735e-4226-b52d-9127a1080aa2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216243
Listing Expiration 2026-12-31
Marketing Start 2022-06-06

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64330635
Hyphenated Format 64330-635

Supplemental Identifiers

RxCUI
856762 856773 856783 856834 856845 856853
UPC
0364330632011 0364330630017 0364330634015 0364330633018 0364330631014 0364330635012
UNII
26LUD4JO9K

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 amitriptyline hydrochloride (source: ndc)
Generic Name amitriptyline hydrochloride (source: ndc)
Application Number ANDA216243 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (64330-635-01)
source: ndc

Packages (1)

64330-635-01 100 TABLET in 1 BOTTLE (64330-635-01)

Ingredients (1)

amitriptyline hydrochloride (150 mg/1)

Linked Drug Pages (1)

Amitriptyline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0a294e70-735e-4226-b52d-9127a1080aa2", "openfda": {"upc": ["0364330632011", "0364330630017", "0364330634015", "0364330633018", "0364330631014", "0364330635012"], "unii": ["26LUD4JO9K"], "rxcui": ["856762", "856773", "856783", "856834", "856845", "856853"], "spl_set_id": ["3d113e43-c694-427f-8b77-66be36a82374"], "manufacturer_name": ["Centaur Pharmaceuticals Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (64330-635-01)", "package_ndc": "64330-635-01", "marketing_start_date": "20220606"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "64330-635_0a294e70-735e-4226-b52d-9127a1080aa2", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "64330-635", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Centaur Pharmaceuticals Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA216243", "marketing_category": "ANDA", "marketing_start_date": "20220606", "listing_expiration_date": "20261231"}