Methylene blue

Orange BookUNIISPLATC V03AB

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeV03AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7071018385
5 VIAL in 1 CARTON (70710-1838-5) / 10 mL in 1 VIAL (70710-1838-1)

Annotations

UNII (FDA Substance ID)

T42P99266K

METHYLENE BLUE

RxCUI 6878

Orange Book

A215636

APAP

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": "70710-1838_9a71c3d4-778d-4566-a060-8ec69cf93871",
  "productndc": "70710-1838",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215636",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/2ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/10ML (5MG/ML)",
        "product_no": "002",
        "approval_date": "Dec 5, 2023"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "5MG/ML (5MG/ML)",
        "product_no": "003",
        "approval_date": "Feb 2, 2026"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100MG/10ML (10MG/ML)",
        "product_no": "004",
        "approval_date": "Mar 31, 2026"
      }
    ],
    "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": "ANDA215636",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methylene blue",
  "start_marketing_date": "20231205",
  "active_numerator_strength": "5"
}

Related drugs

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