Childrens Ibuprofen Oral Suspension Original Berry Flavor

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerPuro Pharma Inc.

CountryUS (United States)

ATC codeG02CC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8347400204
1 BOTTLE in 1 CARTON (83474-002-04) / 118 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

A210602

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WK2XYI10QM",
    "rxcui": "5640",
    "inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
    "display_name": "IBUPROFEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "436c0126-4ff3-c082-e063-6294a90a3d72": {
      "match": "brand_token",
      "title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "83474-002_46f2db1a-4830-abd1-e063-6394a90a735f",
  "productndc": "83474-002",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "210602",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Nov 23, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Childrens Ibuprofen Oral Suspension Original Berry Flavor",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA210602",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IBUPROFEN",
  "start_marketing_date": "20240328",
  "active_numerator_strength": "100"
}

Related drugs

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