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United States · US · US:0078-0509_2765f762-2f4e-4a2b-ac10-cf8149d9a38e

Tegretol

In shortageOrange BookUNIISPLATC N03AF01

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeN03AF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0078050905
    100 TABLET in 1 BOTTLE (0078-0509-05)
  • ndc11
    0078050920
    60 TABLET in 1 BOTTLE (0078-0509-20)

Annotations

UNII (FDA Substance ID)
33CM23913M
CARBAMAZEPINE
RxCUI 2002
Orange Book
N016608
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Carbamazepine Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "33CM23913M",
    "rxcui": "2002",
    "inchikey": "FFGPTBGBLSHEPO-UHFFFAOYSA-N",
    "display_name": "CARBAMAZEPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8d409411-aa9f-4f3a-a52c-fbcb0c3ec053": {
      "match": "brand_token",
      "title": "TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "36",
      "published_date": "2025-12-18"
    }
  },
  "productid": "0078-0509_2765f762-2f4e-4a2b-ac10-cf8149d9a38e",
  "productndc": "0078-0509",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "016608",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBAMAZEPINE",
  "shortage_reason": "Carbamazepine Tablet",
  "shortage_status": "current",
  "proprietary_name": "Tegretol",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA016608",
  "marketing_category": "NDA",
  "nonproprietary_name": "carbamazepine",
  "start_marketing_date": "19680311",
  "active_numerator_strength": "200"
}

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