Pregablin

Orange BookUNIISPLATC N02BF02

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeN02BF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3334216710
90 CAPSULE in 1 BOTTLE (33342-167-10)

Annotations

UNII (FDA Substance ID)

55JG375S6M

PREGABALIN

RxCUI 187832

Orange Book

A205924

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "55JG375S6M",
    "rxcui": "187832",
    "inchikey": "AYXYPKUFHZROOJ-ZETCQYMHSA-N",
    "display_name": "PREGABALIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a3a94949-3060-4057-9b29-e06a808cbd76": {
      "match": "brand_token",
      "title": "PREGABLIN CAPSULE [MACLEODS PHARMACEUTICALS LIMITED]",
      "spl_version": "2",
      "published_date": "2025-07-07"
    }
  },
  "productid": "33342-167_cb84edec-54d3-4100-99d9-b513cc6cbf1e",
  "productndc": "33342-167",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205924",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Nov 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Nov 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Nov 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Nov 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "150MG",
        "product_no": "005",
        "approval_date": "Nov 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "006",
        "approval_date": "Nov 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "225MG",
        "product_no": "007",
        "approval_date": "Nov 12, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "008",
        "approval_date": "Nov 12, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREGABALIN",
  "proprietary_name": "Pregablin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205924",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pregablin",
  "start_marketing_date": "20241113",
  "active_numerator_strength": "75"
}

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