carbamazepine

In shortageOrange BookUNIISPLATC N03AF01

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeN03AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7077114681
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1468-1)
ndc11
7077114683
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1468-3)
ndc11
7077114684
10 BLISTER PACK in 1 CARTON (70771-1468-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
7077114689
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1468-9)

Annotations

UNII (FDA Substance ID)

33CM23913M

CARBAMAZEPINE

RxCUI 2002

Orange Book

A205571

ABABAB

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": {
    "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": "70771-1468_83671980-7b16-469c-8b99-2dcf846df494",
  "productndc": "70771-1468",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205571",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Feb 7, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Feb 7, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Feb 7, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBAMAZEPINE",
  "shortage_reason": "Carbamazepine Capsule, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "carbamazepine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205571",
  "marketing_category": "ANDA",
  "nonproprietary_name": "carbamazepine",
  "start_marketing_date": "20190312",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N03AF01.

Access this data programmatically

Query carbamazepine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs