nortriptyline hydrochloride

Generic: nortriptyline hydrochloride

Labeler: mayne pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nortriptyline hydrochloride
Generic Name nortriptyline hydrochloride
Labeler mayne pharma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nortriptyline hydrochloride 25 mg/1

Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 51862-016
Product ID 51862-016_912a2e7c-3615-4dff-b8b8-27eed882ab3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073556
Listing Expiration 2026-12-31
Marketing Start 2016-06-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862016
Hyphenated Format 51862-016

Supplemental Identifiers

RxCUI
198045 198046 198047 317136
UPC
0351862016013 0351862017010 0351862015016
UNII
00FN6IH15D

Packaging Origin

Original Packager
true

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 ANDA073556 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1000 CAPSULE in 1 BOTTLE, PLASTIC (51862-016-10)
source: ndc

Packages (1)

51862-016-10 1000 CAPSULE in 1 BOTTLE, PLASTIC (51862-016-10)

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": "912a2e7c-3615-4dff-b8b8-27eed882ab3f", "openfda": {"upc": ["0351862016013", "0351862017010", "0351862015016"], "unii": ["00FN6IH15D"], "rxcui": ["198045", "198046", "198047", "317136"], "spl_set_id": ["765d726b-fd4b-4ef7-afd7-9e7e9bf8cae6"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE, PLASTIC (51862-016-10)", "package_ndc": "51862-016-10", "marketing_start_date": "20160601"}], "brand_name": "Nortriptyline Hydrochloride", "product_id": "51862-016_912a2e7c-3615-4dff-b8b8-27eed882ab3f", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "51862-016", "generic_name": "Nortriptyline Hydrochloride", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nortriptyline Hydrochloride", "active_ingredients": [{"name": "NORTRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA073556", "marketing_category": "ANDA", "marketing_start_date": "20160601", "listing_expiration_date": "20261231"}