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United States · US · US:71288-811_65ff33db-d8c2-4591-8988-78e08b2298b6

Methylene Blue

Orange BookUNIISPLATC V03AB

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeV03AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7128881111
    5 VIAL, SINGLE-DOSE in 1 CARTON (71288-811-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-811-10)

Annotations

UNII (FDA Substance ID)
T42P99266K
METHYLENE BLUE
RxCUI 6878
Orange Book
A217380
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "T42P99266K",
    "rxcui": "6878",
    "inchikey": "XQAXGZLFSSPBMK-UHFFFAOYSA-M",
    "display_name": "METHYLENE BLUE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "d115faab-577f-4299-87ed-8d4f909b4659": {
      "match": "brand_token",
      "title": "METHYLENE BLUE INJECTION, SOLUTION [OLIC (THAILAND) LIMITED]",
      "spl_version": "1",
      "published_date": "2026-04-17"
    }
  },
  "productid": "71288-811_65ff33db-d8c2-4591-8988-78e08b2298b6",
  "productndc": "71288-811",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "217380",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/10ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 23, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLENE BLUE",
  "proprietary_name": "Methylene Blue",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA217380",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methylene Blue",
  "start_marketing_date": "20250123",
  "active_numerator_strength": "5"
}

Related drugs

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