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United States · US · US:0093-0109_042aa2c6-95ff-410a-abcf-a8ee79fa96d8

Carbamazepine

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 · 2

  • ndc11
    0093010901
    100 TABLET in 1 BOTTLE (0093-0109-01)
  • ndc11
    0093010910
    1000 TABLET in 1 BOTTLE (0093-0109-10)

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 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": {
    "d3cd36c4-b25e-4716-be1d-0b2c83ea6a03": {
      "match": "brand_token",
      "title": "CARBAMAZEPINE (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "2",
      "published_date": "2026-05-29"
    }
  },
  "productid": "0093-0109_042aa2c6-95ff-410a-abcf-a8ee79fa96d8",
  "productndc": "0093-0109",
  "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 Tablet",
  "shortage_status": "current",
  "proprietary_name": "Carbamazepine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA070541",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbamazepine",
  "start_marketing_date": "19900930",
  "active_numerator_strength": "200"
}

Related drugs

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