amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 50 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2802
Product ID 71335-2802_b24ae4bb-d299-4a13-9cbe-6568dc4090cd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212654
Listing Expiration 2026-12-31
Marketing Start 2024-05-20

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352802
Hyphenated Format 71335-2802

Supplemental Identifiers

RxCUI
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 ANDA212654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (71335-2802-1)
  • 30 TABLET, COATED in 1 BOTTLE (71335-2802-2)
  • 60 TABLET, COATED in 1 BOTTLE (71335-2802-3)
  • 90 TABLET, COATED in 1 BOTTLE (71335-2802-4)
  • 20 TABLET, COATED in 1 BOTTLE (71335-2802-5)
  • 28 TABLET, COATED in 1 BOTTLE (71335-2802-6)
  • 56 TABLET, COATED in 1 BOTTLE (71335-2802-7)
  • 180 TABLET, COATED in 1 BOTTLE (71335-2802-8)
source: ndc

Packages (8)

71335-2802-1 100 TABLET, COATED in 1 BOTTLE (71335-2802-1) 71335-2802-2 30 TABLET, COATED in 1 BOTTLE (71335-2802-2) 71335-2802-3 60 TABLET, COATED in 1 BOTTLE (71335-2802-3) 71335-2802-4 90 TABLET, COATED in 1 BOTTLE (71335-2802-4) 71335-2802-5 20 TABLET, COATED in 1 BOTTLE (71335-2802-5) 71335-2802-6 28 TABLET, COATED in 1 BOTTLE (71335-2802-6) 71335-2802-7 56 TABLET, COATED in 1 BOTTLE (71335-2802-7) 71335-2802-8 180 TABLET, COATED in 1 BOTTLE (71335-2802-8)

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": "b24ae4bb-d299-4a13-9cbe-6568dc4090cd", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856845"], "spl_set_id": ["db4d83b8-3ce7-433e-b32a-a8dc2f44b909"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (71335-2802-1)", "package_ndc": "71335-2802-1", "marketing_start_date": "20251003"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (71335-2802-2)", "package_ndc": "71335-2802-2", "marketing_start_date": "20251003"}, {"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (71335-2802-3)", "package_ndc": "71335-2802-3", "marketing_start_date": "20251003"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (71335-2802-4)", "package_ndc": "71335-2802-4", "marketing_start_date": "20251003"}, {"sample": false, "description": "20 TABLET, COATED in 1 BOTTLE (71335-2802-5)", "package_ndc": "71335-2802-5", "marketing_start_date": "20251003"}, {"sample": false, "description": "28 TABLET, COATED in 1 BOTTLE (71335-2802-6)", "package_ndc": "71335-2802-6", "marketing_start_date": "20251003"}, {"sample": false, "description": "56 TABLET, COATED in 1 BOTTLE (71335-2802-7)", "package_ndc": "71335-2802-7", "marketing_start_date": "20251003"}, {"sample": false, "description": "180 TABLET, COATED in 1 BOTTLE (71335-2802-8)", "package_ndc": "71335-2802-8", "marketing_start_date": "20251003"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "71335-2802_b24ae4bb-d299-4a13-9cbe-6568dc4090cd", "dosage_form": "TABLET, COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "71335-2802", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA212654", "marketing_category": "ANDA", "marketing_start_date": "20240520", "listing_expiration_date": "20261231"}