amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amitriptyline hydrochloride
Generic Name amitriptyline hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

amitriptyline hydrochloride 50 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4469
Product ID 70518-4469_44e417ef-3166-675d-e063-6394a90a7615
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212654
Listing Expiration 2026-12-31
Marketing Start 2025-09-08

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184469
Hyphenated Format 70518-4469

Supplemental Identifiers

RxCUI
856845
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
  • 50 mg/1
source: ndc
Packaging
  • 90 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-4469-0)
  • 30 TABLET, COATED in 1 BLISTER PACK (70518-4469-1)
  • 30 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-4469-2)
source: ndc

Packages (3)

70518-4469-0 90 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-4469-0) 70518-4469-1 30 TABLET, COATED in 1 BLISTER PACK (70518-4469-1) 70518-4469-2 30 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-4469-2)

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": "44e417ef-3166-675d-e063-6394a90a7615", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856845"], "spl_set_id": ["56379133-cd11-4dff-b511-7cdfc9a360ca"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-4469-0)", "package_ndc": "70518-4469-0", "marketing_start_date": "20250908"}, {"sample": false, "description": "30 TABLET, COATED in 1 BLISTER PACK (70518-4469-1)", "package_ndc": "70518-4469-1", "marketing_start_date": "20250908"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-4469-2)", "package_ndc": "70518-4469-2", "marketing_start_date": "20251130"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "70518-4469_44e417ef-3166-675d-e063-6394a90a7615", "dosage_form": "TABLET, COATED", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "70518-4469", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amitriptyline Hydrochloride", "active_ingredients": [{"name": "AMITRIPTYLINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA212654", "marketing_category": "ANDA", "marketing_start_date": "20250908", "listing_expiration_date": "20261231"}