Pregabalin

Orange BookUNIISPLATC N02BF02

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

Identification

ManufacturerExelan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN02BF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7628257405
500 CAPSULE in 1 BOTTLE (76282-574-05)
ndc11
7628257490
90 CAPSULE in 1 BOTTLE (76282-574-90)

Annotations

UNII (FDA Substance ID)

55JG375S6M

PREGABALIN

RxCUI 187832

Orange Book

A211384

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": {
    "34846423-e747-42c5-9bcd-f99c557c4f67": {
      "match": "brand_token",
      "title": "PREGABALIN CAPSULE [PROFICIENT RX LP]",
      "spl_version": "1",
      "published_date": "2026-05-29"
    }
  },
  "productid": "76282-574_b26b72af-62e4-4eb5-9cb8-e4eb05a22435",
  "productndc": "76282-574",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211384",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "005",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "006",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "225MG",
        "product_no": "007",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "008",
        "approval_date": "Jul 19, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREGABALIN",
  "proprietary_name": "Pregabalin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211384",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PREGABALIN",
  "start_marketing_date": "20190719",
  "active_numerator_strength": "225"
}

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