Carbamazepine

In shortageOrange BookUNIISPLATC N03AF01

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeN03AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6787779701
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-797-01)
ndc11
6787779705
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-797-05)
ndc11
6787779730
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-797-30)
ndc11
6787779733
1 BLISTER PACK in 1 CARTON (67877-797-33) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

33CM23913M

CARBAMAZEPINE

RxCUI 2002

Orange Book

A217277

ABABAB

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": "67877-797_f712b540-b6b2-4fc7-a7b4-38b3a8e51964",
  "productndc": "67877-797",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "217277",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jan 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jan 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Jan 14, 2025"
      }
    ],
    "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": "ANDA217277",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Carbamazepine",
  "start_marketing_date": "20251101",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N03AF01.

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