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 25 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-863
Product ID 43063-863_32d56895-edf7-1415-e063-6294a90a911b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202446
Marketing Start 2014-12-05
Marketing End 2026-03-31

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063863
Hyphenated Format 43063-863

Supplemental Identifiers

RxCUI
856834
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 ANDA202446 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-863-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-863-30)
source: ndc

Packages (2)

43063-863-28 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-863-28) 43063-863-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-863-30)

Ingredients (1)

amitriptyline hydrochloride (25 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": "32d56895-edf7-1415-e063-6294a90a911b", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856834"], "spl_set_id": ["964fd565-25db-472a-bbf6-abdc81f1ef0b"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-863-28)", "package_ndc": "43063-863-28", "marketing_end_date": "20260331", "marketing_start_date": "20190924"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-863-30)", "package_ndc": "43063-863-30", "marketing_end_date": "20260331", "marketing_start_date": "20180621"}], "brand_name": "AMITRIPTYLINE HYDROCHLORIDE", "product_id": "43063-863_32d56895-edf7-1415-e063-6294a90a911b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "43063-863", "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": "25 mg/1"}], "application_number": "ANDA202446", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20141205"}