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United States · US · US:31722-658_1814ba82-76cc-c580-e063-6294a90a5e57

DIMETHYL FUMARATE

Orange BookUNIISPLATC L04AX07

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL04AX07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3172265831
    1 BOTTLE in 1 CARTON (31722-658-31) / 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    3172265832
    1 BOTTLE in 1 CARTON (31722-658-32) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    3172265833
    10 BLISTER PACK in 1 CARTON (31722-658-33) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
FO2303MNI2
DIMETHYL FUMARATE
RxCUI 1373478
Orange Book
A210500
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "FO2303MNI2",
    "rxcui": "1373478",
    "inchikey": "LDCRTTXIJACKKU-ONEGZZNKSA-N",
    "display_name": "DIMETHYL FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "31722-658_1814ba82-76cc-c580-e063-6294a90a5e57",
  "productndc": "31722-658",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "210500",
    "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": "DIMETHYL FUMARATE",
  "proprietary_name": "DIMETHYL FUMARATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210500",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DIMETHYL FUMARATE",
  "start_marketing_date": "20200924",
  "active_numerator_strength": "240"
}

Related drugs

Other records sharing ATC code L04AX07.

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