Pregabalin

Orange BookUNIISPLATC N02BF02

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeN02BF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6787746505
500 CAPSULE in 1 BOTTLE (67877-465-05)
ndc11
6787746530
30 CAPSULE in 1 BOTTLE (67877-465-30)
ndc11
6787746533
1 BLISTER PACK in 1 CARTON (67877-465-33) / 10 CAPSULE in 1 BLISTER PACK
ndc11
6787746538
10 BLISTER PACK in 1 CARTON (67877-465-38) / 10 CAPSULE in 1 BLISTER PACK
ndc11
6787746590
90 CAPSULE in 1 BOTTLE (67877-465-90)

Annotations

UNII (FDA Substance ID)

55JG375S6M

PREGABALIN

RxCUI 187832

Orange Book

A207799

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": "67877-465_bf3e2485-edec-4163-b3ff-0e671f12df15",
  "productndc": "67877-465",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207799",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "001",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "225MG",
        "product_no": "005",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "006",
        "approval_date": "Jul 19, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "007",
        "approval_date": "Sep 30, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "008",
        "approval_date": "Sep 30, 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": "ANDA207799",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pregabalin",
  "start_marketing_date": "20190721",
  "active_numerator_strength": "100"
}

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