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 72789-305
Product ID 72789-305_4bbc12f8-bd28-29b4-e063-6394a90a2a25
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214548
Listing Expiration 2027-12-31
Marketing Start 2021-05-26

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789305
Hyphenated Format 72789-305

Supplemental Identifiers

RxCUI
856834
UPC
0372789305301
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 ANDA214548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-305-30)
source: ndc

Packages (1)

72789-305-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-305-30)

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": "4bbc12f8-bd28-29b4-e063-6394a90a2a25", "openfda": {"upc": ["0372789305301"], "unii": ["26LUD4JO9K"], "rxcui": ["856834"], "spl_set_id": ["451b8742-8b3c-4335-9075-c1d8313cd3d0"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-305-30)", "package_ndc": "72789-305-30", "marketing_start_date": "20220302"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "72789-305_4bbc12f8-bd28-29b4-e063-6394a90a2a25", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "72789-305", "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": "ANDA214548", "marketing_category": "ANDA", "marketing_start_date": "20210526", "listing_expiration_date": "20271231"}