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United States · US · US:69097-361_6cf78fd3-5be6-412c-acdf-f599efaf0654

grisofulvin

Orange BookUNIISPLATC D01AA08

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

Identification

ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeD01AA08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6909736108
    120 mL in 1 BOTTLE (69097-361-08)

Annotations

UNII (FDA Substance ID)
32HRV3E3D5
GRISEOFULVIN
RxCUI 5021
Orange Book
A065354
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "32HRV3E3D5",
    "rxcui": "5021",
    "inchikey": "DDUHZTYCFQRHIY-RBHXEPJQSA-N",
    "display_name": "GRISEOFULVIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d5c737e5-51b8-4322-a2a5-4d4a392c1f56": {
      "match": "brand_token",
      "title": "GRISOFULVIN SUSPENSION [CIPLA USA INC.]",
      "spl_version": "6",
      "published_date": "2024-03-28"
    }
  },
  "productid": "69097-361_6cf78fd3-5be6-412c-acdf-f599efaf0654",
  "productndc": "69097-361",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "065354",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG/5ML",
        "product_no": "001",
        "approval_date": "Sep 10, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GRISEOFULVIN",
  "proprietary_name": "grisofulvin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065354",
  "marketing_category": "ANDA",
  "nonproprietary_name": "grisofulvin",
  "start_marketing_date": "20170306",
  "active_numerator_strength": "125"
}

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