EQUETRO

In shortageOrange BookUNIISPLATC N03AF01

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

Identification

ManufacturerValidus Pharmaceuticals LLC

CountryUS (United States)

ATC codeN03AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3069842112
120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-421-12)

Annotations

UNII (FDA Substance ID)

33CM23913M

CARBAMAZEPINE

RxCUI 2002

Orange Book

N021710

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": {
    "be478f3c-40f6-47cc-8ab9-f420a9372b1c": {
      "match": "brand_token",
      "title": "EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]",
      "spl_version": "10",
      "published_date": "2025-08-21"
    }
  },
  "productid": "30698-421_3cbb63f0-feee-fc41-e063-6294a90a5d40",
  "productndc": "30698-421",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021710",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 10, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Dec 10, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Dec 10, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBAMAZEPINE",
  "shortage_reason": "Carbamazepine Capsule, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "EQUETRO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021710",
  "marketing_category": "NDA",
  "nonproprietary_name": "Carbamazepine",
  "start_marketing_date": "20041210",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code N03AF01.

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