PREGABALIN

Orange BookUNIISPLATC N02BF02

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

Identification

ManufacturerNovadoz Pharmaceuticals LLC

CountryUS (United States)

ATC codeN02BF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7220507730
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-077-30)

Annotations

UNII (FDA Substance ID)

55JG375S6M

PREGABALIN

RxCUI 187832

Orange Book

A213226

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": {
    "34846423-e747-42c5-9bcd-f99c557c4f67": {
      "match": "brand_token",
      "title": "PREGABALIN CAPSULE [PROFICIENT RX LP]",
      "spl_version": "1",
      "published_date": "2026-05-29"
    }
  },
  "productid": "72205-077_f6aa5977-97c8-4a56-8e35-d9ab5cc24369",
  "productndc": "72205-077",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "213226",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "82.5MG",
        "product_no": "001",
        "approval_date": "Apr 13, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "165MG",
        "product_no": "002",
        "approval_date": "Apr 13, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "330MG",
        "product_no": "003",
        "approval_date": "Apr 13, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREGABALIN",
  "proprietary_name": "PREGABALIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213226",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PREGABALIN",
  "start_marketing_date": "20210413",
  "active_numerator_strength": "82.5"
}

Related drugs

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