PREGABALIN capsules, CV

Orange BookUNIISPLATC N02BF02

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

Identification

ManufacturerCipla USA Inc.

CountryUS (United States)

ATC codeN02BF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6909767705
90 CAPSULE in 1 BOTTLE (69097-677-05)

Annotations

UNII (FDA Substance ID)

55JG375S6M

PREGABALIN

RxCUI 187832

Orange Book

A212280

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": "69097-677_22a469ee-1346-4abb-84f1-4c2caf26437b",
  "productndc": "69097-677",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "212280",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jan 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jan 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Jan 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Jan 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "150MG",
        "product_no": "005",
        "approval_date": "Jan 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "006",
        "approval_date": "Jan 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "225MG",
        "product_no": "007",
        "approval_date": "Jan 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "008",
        "approval_date": "Jan 10, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREGABALIN",
  "proprietary_name": "PREGABALIN capsules, CV",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212280",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PREGABALIN capsules, CV",
  "start_marketing_date": "20200110",
  "active_numerator_strength": "25"
}

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