CARBAMAZEPINE

In shortageOrange BookUNIISPLATC N03AF01

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

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC codeN03AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0904617250
2000 TABLET in 1 BOTTLE (0904-6172-50)
ndc11
0904617261
100 BLISTER PACK in 1 CARTON (0904-6172-61) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

33CM23913M

CARBAMAZEPINE

RxCUI 2002

Orange Book

A077272

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": "0904-6172_4da43d38-dcd6-4447-8693-5e41e78aacbe",
  "productndc": "0904-6172",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077272",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 7, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Dec 7, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Dec 7, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Dec 7, 2005"
      }
    ],
    "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": "ANDA077272",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CARBAMAZEPINE",
  "start_marketing_date": "20100920",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code N03AF01.

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