amitriptyline hydrochloride

Generic: amitriptyline hydrochloride

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

Drug Facts

Product Profile

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

amitriptyline hydrochloride 25 mg/1

Manufacturer
AiPing Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 11788-078
Product ID 11788-078_4ee04ba3-df06-44c2-8476-09b6cd38f863
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212654
Listing Expiration 2026-12-31
Marketing Start 2025-11-01

Pharmacologic Class

Classes
tricyclic antidepressant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11788078
Hyphenated Format 11788-078

Supplemental Identifiers

RxCUI
856762 856773 856783 856834 856845 856853
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 ANDA212654 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (11788-078-01)
  • 1000 TABLET in 1 BOTTLE (11788-078-10)
source: ndc

Packages (2)

11788-078-01 100 TABLET in 1 BOTTLE (11788-078-01) 11788-078-10 1000 TABLET in 1 BOTTLE (11788-078-10)

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": "4ee04ba3-df06-44c2-8476-09b6cd38f863", "openfda": {"unii": ["26LUD4JO9K"], "rxcui": ["856762", "856773", "856783", "856834", "856845", "856853"], "spl_set_id": ["33807ee6-8443-4613-8bbe-d66f6010fc60"], "manufacturer_name": ["AiPing Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (11788-078-01)", "package_ndc": "11788-078-01", "marketing_start_date": "20251101"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (11788-078-10)", "package_ndc": "11788-078-10", "marketing_start_date": "20251101"}], "brand_name": "Amitriptyline Hydrochloride", "product_id": "11788-078_4ee04ba3-df06-44c2-8476-09b6cd38f863", "dosage_form": "TABLET", "pharm_class": ["Tricyclic Antidepressant [EPC]"], "product_ndc": "11788-078", "generic_name": "Amitriptyline Hydrochloride", "labeler_name": "AiPing Pharmaceutical, Inc.", "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": "20251101", "listing_expiration_date": "20261231"}