amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: st. mary's medical park pharmacy
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler st. mary's medical park pharmacy
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 25 mg/1

Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY

Identifiers & Regulatory

Product NDC 60760-838
Product ID 60760-838_35aa6dbf-04d9-6a1d-e063-6294a90a6afa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212654
Listing Expiration 2026-12-31
Marketing Start 2024-05-20

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60760838
Hyphenated Format 60760-838

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 ANDA212654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-838-30)
source: ndc

Packages (1)

60760-838-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-838-30)

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": "35aa6dbf-04d9-6a1d-e063-6294a90a6afa", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856834"], "spl_set_id": ["35aa7ab3-321a-97f7-e063-6294a90a91e2"], "manufacturer_name": ["ST. MARY'S MEDICAL PARK PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-838-30)", "package_ndc": "60760-838-30", "marketing_start_date": "20250515"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "60760-838_35aa6dbf-04d9-6a1d-e063-6294a90a6afa", "dosage_form": "TABLET, COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "60760-838", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "ST. MARY'S MEDICAL PARK PHARMACY", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA212654", "marketing_category": "ANDA", "marketing_start_date": "20240520", "listing_expiration_date": "20261231"}