Spinraza

Orange BookUNIISPLATC M09AX07

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

Identification

ManufacturerBiogen Inc.

CountryUS (United States)

ATC codeM09AX07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6440603701
1 VIAL, SINGLE-USE in 1 BOX (64406-037-01) / 5 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

5Z9SP3X666

NUSINERSEN

RxCUI 1863556

Orange Book

N209531

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5Z9SP3X666",
    "rxcui": "1863556",
    "inchikey": null,
    "display_name": "NUSINERSEN",
    "substance_type": "nucleicAcid",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRATHECAL",
  "spl_meta": {
    "dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94": {
      "match": "brand_token",
      "title": "SPINRAZA (NUSINERSEN) INJECTION, SOLUTION [BIOGEN INC.]",
      "spl_version": "21",
      "published_date": "2026-04-06"
    }
  },
  "productid": "64406-037_cb572584-c0fd-42aa-b6d1-6dd8260028b5",
  "productndc": "64406-037",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209531",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Dec 23, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Mar 27, 2026"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE/5ML (EQ 10MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Mar 27, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NUSINERSEN",
  "proprietary_name": "Spinraza",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA209531",
  "marketing_category": "NDA",
  "nonproprietary_name": "Nusinersen",
  "start_marketing_date": "20260327",
  "active_numerator_strength": "10"
}

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