amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-703
Product ID 71610-703_ee8718a4-d803-4a58-9c87-06987c7dd356
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089399
Listing Expiration 2026-12-31
Marketing Start 1987-07-14

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610703
Hyphenated Format 71610-703

Supplemental Identifiers

RxCUI
856783 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 ANDA089399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-60)
source: ndc

Packages (3)

71610-703-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-30) 71610-703-53 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-53) 71610-703-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-60)

Ingredients (1)

amitriptyline hydrochloride (25 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": "ee8718a4-d803-4a58-9c87-06987c7dd356", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856783", "856834", "856845"], "spl_set_id": ["4e0f3b15-3621-48a1-9f2b-b0a373920360"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-30)", "package_ndc": "71610-703-30", "marketing_start_date": "20230426"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-53)", "package_ndc": "71610-703-53", "marketing_start_date": "20230427"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-60)", "package_ndc": "71610-703-60", "marketing_start_date": "20230426"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "71610-703_ee8718a4-d803-4a58-9c87-06987c7dd356", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "71610-703", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA089399", "marketing_category": "ANDA", "marketing_start_date": "19870714", "listing_expiration_date": "20261231"}