Back to search
🇺🇸

United States · US · US:0378-0277_20875d8f-5848-4892-a7fb-ab36b0288215

Chlordiazepoxide and Amitriptyline Hydrochloride

Orange BookUNIISPLATC N06AA

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

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0378027701
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0277-01)
  • ndc11
    0378027705
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0277-05)

Annotations

UNII (FDA Substance ID)
26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDE
RxCUI 203168
Orange Book
A071297
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": {
    "511264f5-024b-350a-e063-6394a90a51e9": {
      "match": "brand_token",
      "title": "CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [COUPER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-07"
    }
  },
  "productid": "0378-0277_20875d8f-5848-4892-a7fb-ab36b0288215",
  "productndc": "0378-0277",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "071297",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 25MG BASE;10MG",
        "product_no": "001",
        "approval_date": "Dec 10, 1986"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 12.5MG BASE;5MG",
        "product_no": "002",
        "approval_date": "Dec 10, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE",
  "proprietary_name": "Chlordiazepoxide and Amitriptyline Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA071297",
  "marketing_category": "ANDA",
  "nonproprietary_name": "chlordiazepoxide and amitriptyline hydrochloride",
  "start_marketing_date": "19861210",
  "active_numerator_strength": "27.98; 10"
}

Related drugs

Other records sharing ATC code N06AA.

Access this data programmatically

Query Chlordiazepoxide and 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.