nortriptyline hydrochloride

Generic: nortriptyline hydrochloride

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nortriptyline hydrochloride
Generic Name nortriptyline hydrochloride
Labeler zydus lifesciences limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nortriptyline hydrochloride 10 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1612
Product ID 70771-1612_b2965133-3b71-4cdb-8676-235882e57beb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213441
Listing Expiration 2026-12-31
Marketing Start 2022-02-10

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711612
Hyphenated Format 70771-1612

Supplemental Identifiers

RxCUI
198045 198046 198047 317136
UPC
0370771161331
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 ANDA213441 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (70771-1612-1)
  • 30 CAPSULE in 1 BOTTLE (70771-1612-3)
  • 500 CAPSULE in 1 BOTTLE (70771-1612-5)
source: ndc

Packages (3)

70771-1612-1 100 CAPSULE in 1 BOTTLE (70771-1612-1) 70771-1612-3 30 CAPSULE in 1 BOTTLE (70771-1612-3) 70771-1612-5 500 CAPSULE in 1 BOTTLE (70771-1612-5)

Ingredients (1)

nortriptyline hydrochloride (10 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": "b2965133-3b71-4cdb-8676-235882e57beb", "openfda": {"upc": ["0370771161331"], "unii": ["00FN6IH15D"], "rxcui": ["198045", "198046", "198047", "317136"], "spl_set_id": ["f22dce73-b895-4fe2-8cf7-816dca93c246"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (70771-1612-1)", "package_ndc": "70771-1612-1", "marketing_start_date": "20220210"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (70771-1612-3)", "package_ndc": "70771-1612-3", "marketing_start_date": "20220210"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (70771-1612-5)", "package_ndc": "70771-1612-5", "marketing_start_date": "20220210"}], "brand_name": "Nortriptyline Hydrochloride", "product_id": "70771-1612_b2965133-3b71-4cdb-8676-235882e57beb", "dosage_form": "CAPSULE", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "70771-1612", "generic_name": "Nortriptyline Hydrochloride", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nortriptyline Hydrochloride", "active_ingredients": [{"name": "NORTRIPTYLINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA213441", "marketing_category": "ANDA", "marketing_start_date": "20220210", "listing_expiration_date": "20261231"}