nortriptyline hydrochloride

Generic: nortriptyline hydrochloride

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

Drug Facts

Product Profile

Brand Name nortriptyline hydrochloride
Generic Name nortriptyline hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nortriptyline hydrochloride 25 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8568
Product ID 68788-8568_11725d25-b6d9-4270-856d-418e4353be9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074132
Listing Expiration 2026-12-31
Marketing Start 2024-01-18

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888568
Hyphenated Format 68788-8568

Supplemental Identifiers

RxCUI
317136
UNII
00FN6IH15D

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 nortriptyline hydrochloride (source: ndc)
Generic Name nortriptyline hydrochloride (source: ndc)
Application Number ANDA074132 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (68788-8568-3)
source: ndc

Packages (1)

68788-8568-3 30 CAPSULE in 1 BOTTLE (68788-8568-3)

Ingredients (1)

nortriptyline hydrochloride (25 mg/1)

Linked Drug Pages (1)

Nortriptyline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "11725d25-b6d9-4270-856d-418e4353be9f", "openfda": {"unii": ["00FN6IH15D"], "rxcui": ["317136"], "spl_set_id": ["af950b46-07df-4de6-a221-d3d7059b87a1"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8568-3)", "package_ndc": "68788-8568-3", "marketing_start_date": "20240118"}], "brand_name": "Nortriptyline Hydrochloride", "product_id": "68788-8568_11725d25-b6d9-4270-856d-418e4353be9f", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "68788-8568", "generic_name": "Nortriptyline Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nortriptyline Hydrochloride", "active_ingredients": [{"name": "NORTRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA074132", "marketing_category": "ANDA", "marketing_start_date": "20240118", "listing_expiration_date": "20261231"}