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United States · US · US:0093-0090_5c31da75-fc21-4ab2-9487-64169767ebd0

Epitol

In shortageOrange BookUNIISPLATC N03AF01

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeN03AF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0093009001
    100 TABLET in 1 BOTTLE (0093-0090-01)

Annotations

UNII (FDA Substance ID)
33CM23913M
CARBAMAZEPINE
RxCUI 2002
Orange Book
A070541
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Carbamazepine Capsule, Extended Release
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": {
    "32bbe864-7374-44da-8c6e-e733f0648243": {
      "match": "brand_token",
      "title": "EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "18",
      "published_date": "2025-08-25"
    }
  },
  "productid": "0093-0090_5c31da75-fc21-4ab2-9487-64169767ebd0",
  "productndc": "0093-0090",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "070541",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Sep 17, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBAMAZEPINE",
  "shortage_reason": "Carbamazepine Capsule, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Epitol",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA070541",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbamazepine",
  "start_marketing_date": "19900930",
  "active_numerator_strength": "200"
}

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