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United States · US · US:54092-173_39171a32-c78d-4130-be53-638e19cf2261

Carbatrol

In shortageOrange BookUNIISPLATC N03AF01

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

Identification

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

Packs · 1

  • ndc11
    5409217312
    120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-173-12)

Annotations

UNII (FDA Substance ID)
33CM23913M
CARBAMAZEPINE
RxCUI 2002
Orange Book
N020712
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": {
    "bc03e499-5bac-4293-bff4-6864153a624d": {
      "match": "brand_token",
      "title": "CARBATROL (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "39",
      "published_date": "2025-07-03"
    }
  },
  "productid": "54092-173_39171a32-c78d-4130-be53-638e19cf2261",
  "productndc": "54092-173",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020712",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Sep 30, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBAMAZEPINE",
  "shortage_reason": "Carbamazepine Tablet",
  "shortage_status": "current",
  "proprietary_name": "Carbatrol",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020712",
  "marketing_category": "NDA",
  "nonproprietary_name": "carbamazepine",
  "start_marketing_date": "19970930",
  "active_numerator_strength": "300"
}

Related drugs

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