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
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 75 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2398
Product ID 71335-2398_88f5f6fe-0f20-4b8e-aff4-a32aa5be8635
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217411
Listing Expiration 2026-12-31
Marketing Start 2023-06-10

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352398
Hyphenated Format 71335-2398

Supplemental Identifiers

RxCUI
856853
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
  • 75 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71335-2398-1)
  • 100 TABLET in 1 BOTTLE (71335-2398-2)
  • 28 TABLET in 1 BOTTLE (71335-2398-3)
  • 60 TABLET in 1 BOTTLE (71335-2398-4)
  • 90 TABLET in 1 BOTTLE (71335-2398-5)
source: ndc

Packages (5)

71335-2398-1 30 TABLET in 1 BOTTLE (71335-2398-1) 71335-2398-2 100 TABLET in 1 BOTTLE (71335-2398-2) 71335-2398-3 28 TABLET in 1 BOTTLE (71335-2398-3) 71335-2398-4 60 TABLET in 1 BOTTLE (71335-2398-4) 71335-2398-5 90 TABLET in 1 BOTTLE (71335-2398-5)

Ingredients (1)

amitriptyline hydrochloride (75 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": "88f5f6fe-0f20-4b8e-aff4-a32aa5be8635", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856853"], "spl_set_id": ["4ce78bf6-61ec-435f-9af5-c86df440892a"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-2398-1)", "package_ndc": "71335-2398-1", "marketing_start_date": "20240529"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (71335-2398-2)", "package_ndc": "71335-2398-2", "marketing_start_date": "20240529"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (71335-2398-3)", "package_ndc": "71335-2398-3", "marketing_start_date": "20240529"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-2398-4)", "package_ndc": "71335-2398-4", "marketing_start_date": "20240529"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-2398-5)", "package_ndc": "71335-2398-5", "marketing_start_date": "20240529"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "71335-2398_88f5f6fe-0f20-4b8e-aff4-a32aa5be8635", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "71335-2398", "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": "75 mg/1"}], "application_number": "ANDA217411", "marketing_category": "ANDA", "marketing_start_date": "20230610", "listing_expiration_date": "20261231"}