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
8280495000
100 CAPSULE in 1 BOTTLE (82804-950-00)
ndc11
8280495011
1000 CAPSULE in 1 BOTTLE (82804-950-11)
ndc11
8280495030
30 CAPSULE in 1 BOTTLE (82804-950-30)
ndc11
8280495055
500 CAPSULE in 1 BOTTLE (82804-950-55)
ndc11
8280495060
60 CAPSULE in 1 BOTTLE (82804-950-60)
ndc11
8280495067
270 CAPSULE in 1 BOTTLE (82804-950-67)
ndc11
8280495072
120 CAPSULE in 1 BOTTLE (82804-950-72)
ndc11
8280495078
180 CAPSULE in 1 BOTTLE (82804-950-78)
ndc11
8280495090
90 CAPSULE in 1 BOTTLE (82804-950-90)

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": "82804-950_34846423-e747-42c5-9bcd-f99c557c4f67",
  "productndc": "82804-950",
  "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": "300"
}

Related drugs

Other records sharing ATC code N02BF02.

Access this data programmatically

Query Pregabalin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs