amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 10 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 57664-687
Product ID 57664-687_326a1cd7-1376-8b5e-e063-6294a90a80aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089399
Listing Expiration 2026-12-31
Marketing Start 1987-07-14

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664687
Hyphenated Format 57664-687

Supplemental Identifiers

RxCUI
856762 856773 856783 856834 856845 856853
UPC
0357664689882 0357664691885 0357664687888 0357664690888 0357664688885 0357664692882
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 ANDA089399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-18)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-88)
source: ndc

Packages (2)

57664-687-18 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-18) 57664-687-88 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-88)

Ingredients (1)

amitriptyline hydrochloride (10 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": "326a1cd7-1376-8b5e-e063-6294a90a80aa", "openfda": {"upc": ["0357664689882", "0357664691885", "0357664687888", "0357664690888", "0357664688885", "0357664692882"], "unii": ["26LUD4JO9K"], "rxcui": ["856762", "856773", "856783", "856834", "856845", "856853"], "spl_set_id": ["4e520c63-1cf6-40f6-a51c-3f9b0e181342"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-18)", "package_ndc": "57664-687-18", "marketing_start_date": "19870714"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-88)", "package_ndc": "57664-687-88", "marketing_start_date": "19870714"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "57664-687_326a1cd7-1376-8b5e-e063-6294a90a80aa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "57664-687", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA089399", "marketing_category": "ANDA", "marketing_start_date": "19870714", "listing_expiration_date": "20261231"}