Lyrica

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 · 2

ndc11
5815123977
90 CAPSULE in 1 BOTTLE (58151-239-77)
ndc11
5815123988
100 BLISTER PACK in 1 CARTON (58151-239-88) / 1 CAPSULE in 1 BLISTER PACK (58151-239-32)

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": "58151-239_1c2af07d-faf4-4fc7-b724-c5166746956d",
  "productndc": "58151-239",
  "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": "20241022",
  "active_numerator_strength": "100"
}

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