amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

amitriptyline hydrochloride 50 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-836
Product ID 43063-836_39fa6955-dc56-8a30-e063-6294a90abf8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085968
Listing Expiration 2026-12-31
Marketing Start 1977-11-29

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063836
Hyphenated Format 43063-836

Supplemental Identifiers

RxCUI
856845
UPC
0343063836309
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 ANDA085968 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-836-30)
source: ndc

Packages (1)

43063-836-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-836-30)

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": "39fa6955-dc56-8a30-e063-6294a90abf8e", "openfda": {"upc": ["0343063836309"], "unii": ["26LUD4JO9K"], "rxcui": ["856845"], "spl_set_id": ["d7bfeb47-2482-4217-b522-df4444499133"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-836-30)", "package_ndc": "43063-836-30", "marketing_start_date": "20180214"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "43063-836_39fa6955-dc56-8a30-e063-6294a90abf8e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "43063-836", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA085968", "marketing_category": "ANDA", "marketing_start_date": "19771129", "listing_expiration_date": "20261231"}