Lamotrigine

In shortageOrange BookUNIISPLATC N03AX09

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN03AX09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6838201005
500 TABLET in 1 BOTTLE (68382-010-05)
ndc11
6838201014
60 TABLET in 1 BOTTLE (68382-010-14)
ndc11
6838201016
90 TABLET in 1 BOTTLE (68382-010-16)

Annotations

UNII (FDA Substance ID)

U3H27498KS

LAMOTRIGINE

RxCUI 28439

Orange Book

A077633

ABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Lamotrigine Tablet, Extended Release

Raw payload (JSON)

{
  "unii": {
    "unii": "U3H27498KS",
    "rxcui": "28439",
    "inchikey": "PYZRQGJRPPTADH-UHFFFAOYSA-N",
    "display_name": "LAMOTRIGINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "68a4dac2-5015-40c5-88ca-204098c3b288": {
      "match": "brand_token",
      "title": "LAMOTRIGINE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68382-010_277200d5-a863-4411-8c1b-aac8d7fde6a6",
  "productndc": "68382-010",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077633",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jan 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jan 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Jan 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "004",
        "approval_date": "Jan 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "005",
        "approval_date": "Jan 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG",
        "product_no": "006",
        "approval_date": "Jan 27, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LAMOTRIGINE",
  "shortage_reason": "Lamotrigine Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Lamotrigine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077633",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lamotrigine",
  "start_marketing_date": "20090127",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code N03AX09.

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