Back to search
🇺🇸

United States · US · US:64330-635_0a294e70-735e-4226-b52d-9127a1080aa2

Amitriptyline Hydrochloride

Orange BookUNIISPLATC N06AA09

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCentaur Pharmaceuticals Private Limited
CountryUS (United States)
ATC codeN06AA09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6433063501
    100 TABLET in 1 BOTTLE (64330-635-01)

Annotations

UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A216243
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "26LUD4JO9K",
    "rxcui": "203168",
    "inchikey": "KFYRPLNVJVHZGT-UHFFFAOYSA-N",
    "display_name": "AMITRIPTYLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ce87013b-bf4a-47d1-9808-7cb8290feb23": {
      "match": "brand_token",
      "title": "AMITRIPTYLINE HYDROCHLORIDE TABLET, COATED [REMEDYREPACK INC.]",
      "spl_version": "5",
      "published_date": "2026-05-04"
    }
  },
  "productid": "64330-635_0a294e70-735e-4226-b52d-9127a1080aa2",
  "productndc": "64330-635",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216243",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 6, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jun 6, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Jun 6, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Jun 6, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "005",
        "approval_date": "Jun 6, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "150MG",
        "product_no": "006",
        "approval_date": "Jun 6, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMITRIPTYLINE HYDROCHLORIDE",
  "proprietary_name": "Amitriptyline Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216243",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amitriptyline Hydrochloride",
  "start_marketing_date": "20220606",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code N06AA09.

Access this data programmatically

Query Amitriptyline Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.