amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 50 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-107
Product ID 16571-107_a83b8840-dd78-46f1-b952-893c30bf5bf9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217411
Listing Expiration 2026-12-31
Marketing Start 2023-06-10

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571107
Hyphenated Format 16571-107

Supplemental Identifiers

RxCUI
856762 856773 856783 856834 856845 856853
UNII
26LUD4JO9K

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 amitriptyline hydrochloride (source: ndc)
Generic Name amitriptyline hydrochloride (source: ndc)
Application Number ANDA217411 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16571-107-01)
  • 1000 TABLET in 1 BOTTLE (16571-107-10)
source: ndc

Packages (2)

16571-107-01 100 TABLET in 1 BOTTLE (16571-107-01) 16571-107-10 1000 TABLET in 1 BOTTLE (16571-107-10)

Ingredients (1)

amitriptyline hydrochloride (50 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": "a83b8840-dd78-46f1-b952-893c30bf5bf9", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856762", "856773", "856783", "856834", "856845", "856853"], "spl_set_id": ["a219a68e-7ce5-4e9d-a0de-ec76960040f6"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16571-107-01)", "package_ndc": "16571-107-01", "marketing_start_date": "20230610"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (16571-107-10)", "package_ndc": "16571-107-10", "marketing_start_date": "20230610"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "16571-107_a83b8840-dd78-46f1-b952-893c30bf5bf9", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "16571-107", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA217411", "marketing_category": "ANDA", "marketing_start_date": "20230610", "listing_expiration_date": "20261231"}