Lyrica CR

Orange BookUNIISPLATC N02BF02

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

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeN02BF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5815124793
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-247-93)

Annotations

UNII (FDA Substance ID)

55JG375S6M

PREGABALIN

RxCUI 187832

Orange Book

N209501

ABABAB

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": "58151-247_67715d17-5ade-44ba-a5db-ba20d30d6da1",
  "productndc": "58151-247",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "209501",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "82.5MG",
        "product_no": "001",
        "approval_date": "Oct 11, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "165MG",
        "product_no": "002",
        "approval_date": "Oct 11, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "330MG",
        "product_no": "003",
        "approval_date": "Oct 11, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREGABALIN",
  "proprietary_name": "Lyrica CR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209501",
  "marketing_category": "NDA",
  "nonproprietary_name": "PREGABALIN",
  "start_marketing_date": "20240711",
  "active_numerator_strength": "330"
}

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