Norpace CR

Orange BookUNIISPLATC C01BA03

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

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc

CountryUS (United States)

ATC codeC01BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)

N6BOM1935W

DISOPYRAMIDE PHOSPHATE

RxCUI 203178

Orange Book

N018655

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "N6BOM1935W",
    "rxcui": "203178",
    "inchikey": "CGDDQFMPGMYYQP-UHFFFAOYSA-N",
    "display_name": "DISOPYRAMIDE PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e2aa1642-d262-4520-bc6a-9fd3ad795677": {
      "match": "brand_token",
      "title": "NORPACE (DISOPYRAMIDE PHOSPHATE) CAPSULE, GELATIN COATED NORPACE CR (DISOPYRAMIDE PHOSPHATE) CAPSULE, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "21",
      "published_date": "2026-03-19"
    }
  },
  "productid": "0025-2732_acc7751f-7484-4d53-8a6b-0194f23da1c8",
  "productndc": "0025-2732",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "018655",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Jul 20, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "002",
        "approval_date": "Jul 20, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DISOPYRAMIDE PHOSPHATE",
  "proprietary_name": "Norpace CR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018655",
  "marketing_category": "NDA",
  "nonproprietary_name": "disopyramide phosphate",
  "start_marketing_date": "19820720",
  "active_numerator_strength": "100"
}

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