amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 50 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7411
Product ID 0904-7411_54771c13-f83b-4c28-b2ed-be967b14d388
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217411
Listing Expiration 2026-12-31
Marketing Start 2024-03-08

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047411
Hyphenated Format 0904-7411

Supplemental Identifiers

RxCUI
856834 856845
UNII
26LUD4JO9K

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 ANDA217411 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7411-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7411-61 100 BLISTER PACK in 1 CARTON (0904-7411-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

amitriptyline hydrochloride (50 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": "54771c13-f83b-4c28-b2ed-be967b14d388", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856834", "856845"], "spl_set_id": ["29ec1221-04d8-4b21-822e-2779fcaae62c"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7411-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7411-61", "marketing_start_date": "20240308"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "0904-7411_54771c13-f83b-4c28-b2ed-be967b14d388", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "0904-7411", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA217411", "marketing_category": "ANDA", "marketing_start_date": "20240308", "listing_expiration_date": "20261231"}