Pregabalin

Orange BookUNIISPLATC N02BF02

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN02BF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4733569108
100 CAPSULE in 1 BOTTLE (47335-691-08)
ndc11
4733569118
1000 CAPSULE in 1 BOTTLE (47335-691-18)
ndc11
4733569183
30 CAPSULE in 1 BOTTLE (47335-691-83)
ndc11
4733569188
100 CAPSULE in 1 BOTTLE (47335-691-88)

Annotations

UNII (FDA Substance ID)

55JG375S6M

PREGABALIN

RxCUI 187832

Orange Book

A091157

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": "47335-691_52bb3d43-24c1-4789-8423-6c2d54850e75",
  "productndc": "47335-691",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "091157",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Nov 29, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Nov 29, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Nov 29, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Nov 29, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "150MG",
        "product_no": "005",
        "approval_date": "Nov 29, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "006",
        "approval_date": "Nov 29, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "225MG",
        "product_no": "007",
        "approval_date": "Nov 29, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "008",
        "approval_date": "Nov 29, 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": "ANDA091157",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pregabalin",
  "start_marketing_date": "20191204",
  "active_numerator_strength": "200"
}

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