Carbamazepine

In shortageOrange BookUNIISPLATC N03AF01

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeN03AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0832602211
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0832-6022-11)

Annotations

UNII (FDA Substance ID)

33CM23913M

CARBAMAZEPINE

RxCUI 2002

Orange Book

A213311

ABABAB

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": {
    "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": "0832-6022_8bbf550a-a827-45cc-85a5-4795ec14e2e5",
  "productndc": "0832-6022",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "213311",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Apr 13, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Apr 13, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Apr 13, 2021"
      }
    ],
    "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": "Carbamazepine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213311",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbamazepine",
  "start_marketing_date": "20210413",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N03AF01.

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