Tegretol

In shortageOrange BookUNIISPLATC N03AF01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeN03AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0078051005
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0510-05)

Annotations

UNII (FDA Substance ID)

33CM23913M

CARBAMAZEPINE

RxCUI 2002

Orange Book

N020234

ABABAB

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": "0078-0510_2765f762-2f4e-4a2b-ac10-cf8149d9a38e",
  "productndc": "0078-0510",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020234",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Mar 25, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Mar 25, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Mar 25, 1996"
      }
    ],
    "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": "NDA020234",
  "marketing_category": "NDA",
  "nonproprietary_name": "carbamazepine",
  "start_marketing_date": "19960325",
  "active_numerator_strength": "100"
}

Related drugs

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