Unishield Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerUnishield

CountryUS (United States)

ATC codeG02CC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4931409933
50 PACKET in 1 BOX (49314-0993-3) / 2 TABLET, COATED in 1 PACKET

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

A075010

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": {
    "ba0ec1eb-db85-6a7f-e053-2995a90aafe5": {
      "match": "brand_token",
      "title": "UNISHIELD EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) TABLET UNISHIELD EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) TABLET, FILM COATED UNISHIELD EXTRA STRENGTH NON ASPIRIN (ACETAMINOPHEN) TABLET [UNISHIELD]",
      "spl_version": "6",
      "published_date": "2026-01-21"
    }
  },
  "productid": "49314-0993_3e5d6ccc-f765-21b5-e063-6394a90a3400",
  "productndc": "49314-0993",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "075010",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Mar 1, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Unishield Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075010",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20210301",
  "active_numerator_strength": "200"
}

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