Carbamazepine

In shortageOrange BookUNIISPLATC N03AF01

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

Identification

ManufacturerChartwell Governmental & Specialty RX, LLC.

CountryUS (United States)

ATC codeN03AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6899980224
2 TRAY in 1 BOX (68999-802-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-802-45)

Annotations

UNII (FDA Substance ID)

33CM23913M

CARBAMAZEPINE

RxCUI 2002

Orange Book

A075714

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": "68999-802_41dd08a0-b89b-6ad3-e063-6394a90afdc6",
  "productndc": "68999-802",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "075714",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Jun 5, 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/5mL",
  "application_number": "ANDA075714",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbamazepine",
  "start_marketing_date": "20020605",
  "active_numerator_strength": "100"
}

Related drugs

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