amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 10 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4092
Product ID 68071-4092_1d8e1fca-6863-7c08-e063-6394a90a08b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202446
Listing Expiration 2026-12-31
Marketing Start 2014-12-05

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680714092
Hyphenated Format 68071-4092

Supplemental Identifiers

RxCUI
856783
UPC
0368071409239
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 ANDA202446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (68071-4092-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68071-4092-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68071-4092-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68071-4092-9)
source: ndc

Packages (4)

68071-4092-2 20 TABLET, FILM COATED in 1 BOTTLE (68071-4092-2) 68071-4092-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-4092-3) 68071-4092-6 60 TABLET, FILM COATED in 1 BOTTLE (68071-4092-6) 68071-4092-9 90 TABLET, FILM COATED in 1 BOTTLE (68071-4092-9)

Ingredients (1)

amitriptyline hydrochloride (10 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": "1d8e1fca-6863-7c08-e063-6394a90a08b6", "openfda": {"upc": ["0368071409239"], "unii": ["26LUD4JO9K"], "rxcui": ["856783"], "spl_set_id": ["58ff9a82-5de6-a1b0-e053-2991aa0a84ba"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68071-4092-2)", "package_ndc": "68071-4092-2", "marketing_start_date": "20170912"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-4092-3)", "package_ndc": "68071-4092-3", "marketing_start_date": "20170912"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68071-4092-6)", "package_ndc": "68071-4092-6", "marketing_start_date": "20170912"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68071-4092-9)", "package_ndc": "68071-4092-9", "marketing_start_date": "20170912"}], "brand_name": "AMITRIPTYLINE HYDROCHLORIDE", "product_id": "68071-4092_1d8e1fca-6863-7c08-e063-6394a90a08b6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "68071-4092", "generic_name": "AMITRIPTYLINE HYDROCHLORIDE", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMITRIPTYLINE HYDROCHLORIDE", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA202446", "marketing_category": "ANDA", "marketing_start_date": "20141205", "listing_expiration_date": "20261231"}