Lyrica

Orange BookUNIISPLATC N02BF02

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

Identification

ManufacturerParke-Davis Div of Pfizer Inc

CountryUS (United States)

ATC codeN02BF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0071101868
90 CAPSULE in 1 BOTTLE (0071-1018-68)

Annotations

UNII (FDA Substance ID)

55JG375S6M

PREGABALIN

RxCUI 187832

Orange Book

N021446

ABABABABABABABAB

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": {
    "f280bbd8-2af2-444a-bd96-e409337ca6dd": {
      "match": "brand_token",
      "title": "LYRICA CR (PREGABALIN) TABLET, FILM COATED, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]",
      "spl_version": "7",
      "published_date": "2026-04-15"
    }
  },
  "productid": "0071-1018_e7c79058-03ba-4e7f-9a31-9ec5ce245161",
  "productndc": "0071-1018",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021446",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Dec 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Dec 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Dec 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Dec 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "005",
        "approval_date": "Dec 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "006",
        "approval_date": "Dec 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "225MG",
        "product_no": "007",
        "approval_date": "Dec 30, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "008",
        "approval_date": "Dec 30, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREGABALIN",
  "proprietary_name": "Lyrica",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021446",
  "marketing_category": "NDA",
  "nonproprietary_name": "PREGABALIN",
  "start_marketing_date": "20041230",
  "active_numerator_strength": "300"
}

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