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United States · US · US:46708-731_a742c03d-10b1-48e2-8df1-48967395ae06

CARBAMAZEPINE

In shortageOrange BookUNIISPLATC N03AF01

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

Identification

ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeN03AF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    4670873110
    100 BLISTER PACK in 1 CARTON (46708-731-10) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    4670873131
    100 TABLET in 1 BOTTLE (46708-731-31)
  • ndc11
    4670873160
    60 TABLET in 1 BOTTLE (46708-731-60)
  • ndc11
    4670873191
    1000 TABLET in 1 BOTTLE (46708-731-91)

Annotations

UNII (FDA Substance ID)
33CM23913M
CARBAMAZEPINE
RxCUI 2002
Orange Book
A216623
AB
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": "46708-731_a742c03d-10b1-48e2-8df1-48967395ae06",
  "productndc": "46708-731",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216623",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Apr 16, 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": "ANDA216623",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CARBAMAZEPINE",
  "start_marketing_date": "20241231",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code N03AF01.

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