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United States · US · US:68788-7210_fc6363d3-830f-49b8-8aea-e34f47ead0d1

CARBAMAZEPINE

In shortageOrange BookUNIISPLATC N03AF01

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

Identification

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

Packs · 6

  • ndc11
    6878872101
    100 TABLET in 1 BOTTLE (68788-7210-1)
  • ndc11
    6878872102
    20 TABLET in 1 BOTTLE (68788-7210-2)
  • ndc11
    6878872103
    30 TABLET in 1 BOTTLE (68788-7210-3)
  • ndc11
    6878872106
    60 TABLET in 1 BOTTLE (68788-7210-6)
  • ndc11
    6878872108
    28 TABLET in 1 BOTTLE (68788-7210-8)
  • ndc11
    6878872109
    90 TABLET in 1 BOTTLE (68788-7210-9)

Annotations

UNII (FDA Substance ID)
33CM23913M
CARBAMAZEPINE
RxCUI 2002
Orange Book
A075948
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": "68788-7210_fc6363d3-830f-49b8-8aea-e34f47ead0d1",
  "productndc": "68788-7210",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075948",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Feb 27, 2002"
      }
    ],
    "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": "ANDA075948",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CARBAMAZEPINE",
  "start_marketing_date": "20180806",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code N03AF01.

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