DIMETHYL FUMARATE

Orange BookSPL

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6923816263
1 KIT in 1 KIT (69238-1626-3) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC

Annotations

Orange Book

A210402

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "b8e5184d-5d1d-0a89-e053-2995a90a2d6d": {
      "match": "brand_token",
      "title": "DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "9",
      "published_date": "2026-05-11"
    }
  },
  "productid": "69238-1626_76c5e6b0-c799-45cf-adb6-2d3845639b62",
  "productndc": "69238-1626",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "210402",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Sep 24, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "240MG",
        "product_no": "002",
        "approval_date": "Sep 24, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "DIMETHYL FUMARATE",
  "active_ingred_unit": null,
  "application_number": "ANDA210402",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DIMETHYL FUMARATE",
  "start_marketing_date": "20200928",
  "active_numerator_strength": null
}

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