Pregabalin

Orange BookUNIISPLATC N02BF02

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeN02BF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
8280494500
100 CAPSULE in 1 BOTTLE (82804-945-00)
ndc11
8280494511
1000 CAPSULE in 1 BOTTLE (82804-945-11)
ndc11
8280494530
30 CAPSULE in 1 BOTTLE (82804-945-30)
ndc11
8280494555
500 CAPSULE in 1 BOTTLE (82804-945-55)
ndc11
8280494560
60 CAPSULE in 1 BOTTLE (82804-945-60)
ndc11
8280494567
270 CAPSULE in 1 BOTTLE (82804-945-67)
ndc11
8280494572
120 CAPSULE in 1 BOTTLE (82804-945-72)
ndc11
8280494578
180 CAPSULE in 1 BOTTLE (82804-945-78)
ndc11
8280494590
90 CAPSULE in 1 BOTTLE (82804-945-90)

Annotations

UNII (FDA Substance ID)

55JG375S6M

PREGABALIN

RxCUI 187832

Orange Book

A212988

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": "82804-945_34846423-e747-42c5-9bcd-f99c557c4f67",
  "productndc": "82804-945",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "212988",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Mar 8, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Mar 8, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Mar 8, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Mar 8, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "005",
        "approval_date": "Mar 8, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "006",
        "approval_date": "Mar 8, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "225MG",
        "product_no": "007",
        "approval_date": "Mar 8, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "008",
        "approval_date": "Mar 8, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREGABALIN",
  "proprietary_name": "Pregabalin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212988",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pregabalin",
  "start_marketing_date": "20251117",
  "active_numerator_strength": "75"
}

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